[Federal Register: March 31, 2003 (Volume 68, Number 61)]
[Proposed Rules]               
[Page 15404-15417]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31mr03-39]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 800

[Docket No. 03N-0056]

 
Medical Devices; Patient Examination and Surgeons' Gloves; Test 
Procedures and Acceptance Criteria

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
the sampling plans, test method, and acceptable quality levels (AQLs) 
for medical gloves contained in its medical device regulations. As 
prescribed by its regulation, FDA samples patient examination and 
surgeons' gloves and examines them for visual defects and water leaks. 
Glove lots are considered adulterated if they do not meet the specified 
quality levels. The objective of the proposed regulation is to improve 
the barrier quality of medical gloves on the U.S. market. The updated 
regulation would accomplish this by reducing the acceptable level of 
defects observed during FDA testing of medical gloves. By reducing the 
AQLs for medical gloves, FDA would also harmonize the level with 
consensus standards developed by the International Organization for 
Standardization (ISO) and the American Society for Testing Materials 
(ASTM).

DATES: Submit written or electronic comments by June 30, 2003. See 
section VII of this document for the proposed effective date of a final 
rule based on this proposal.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments
.

FOR FURTHER INFORMATION CONTACT: Casper E. Uldriks, Office of 
Compliance, Center for Devices and Radiological Health (HFZ-300), Food 
and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, 301-
594-4692.

SUPPLEMENTARY INFORMATION:

I. Background

    With the advent of the human immunodeficiency virus (HIV) 
infections and the progression of infections into acquired immune 
deficiency syndrome (AIDS), scientists and medical and public health 
experts developed risk reduction strategies, including protective and 
preventive strategies for health care workers. These strategies were 
based on the etiology, and mechanisms and routes of transmission, of 
HIV infections.

A. Routes and Mechanisms of HIV Transmission

    HIV is transmitted primarily through sexual contact. However, 
nonsexual transmission occurred in health care settings as a result of 
contact with infected blood. HIV was also isolated from other body 
fluids. The prevalence of HIV infections in health care settings and 
the risk of clinical transmission of other infections increased the 
importance of using effective procedures and barriers. The potential 
for infection heightened the importance of the quality of the barriers 
selected for protection.

B. The Need for Precautions in Health Care Settings

    On August 21, 1987, the Centers For Disease Control (CDC) published 
a report emphasizing the need for all health care workers to routinely 
use appropriate universal precautions when they expect to come into 
contact with blood or other body fluids of any patient (Ref. 1). This 
report recommended that health care workers wear medical gloves when: 
(1) Touching blood or other body fluids, mucous membranes, or non-
intact skin of patients; (2) handling items or surfaces soiled with 
blood or other bodily fluids; and (3) performing venipuncture and other 
vascular access procedures. The collective term, medical gloves, 
includes patient examination and surgeons' gloves (see 21 CFR 880.6250 
and 878.4460).

C. The Need for Testing

    After the publication of the CDC's recommendations, and the rise in 
HIV infections, health care workers increasingly relied on surgeons' 
gloves and patient examination gloves as a barrier to the transmission 
of HIV and other blood- and fluid-borne infectious agents. The CDC's 
recommendations clearly recognized that defects in medical gloves had 
the potential of resulting in transmission of HIV between patients and 
health care workers.
    Consequently, FDA reviewed and evaluated the quality control 
procedures that manufacturers used in making medical gloves. FDA 
concluded that manufacturers could only meet reasonable expectations of 
barrier protection by establishing adequate specifications for medical 
gloves, and adequate test procedures to detect defects in gloves. Glove 
defects include rips, tears, embedded foreign objects in the glove that 
may cause the glove to rip or tear upon stretching, or holes that allow 
the passage of fluids and fluid-borne microorganisms. Each of these 
defects compromises the glove barrier integrity and may expose health 
care workers and patients to infectious agents. Articles written by 
health care professionals who studied glove quality and the use of 
gloves as a barrier to infectious agents noted that gloves with defects 
may not provide this protection (Refs. 2 through 6). In 1989, when FDA 
proposed Sec.  800.20 (21 CFR 800.20), FDA's position was that existing 
consensus standards did not establish adequate test methods and 
acceptance criteria for patient examination or surgeons' gloves (54 FR 
48218, November 21, 1989). Therefore, the agency concluded that it 
needed to communicate clearly the test procedures and the acceptance 
levels it would use to determine whether medical gloves were 
adulterated.

D. The Setting of Adulteration Levels

    In the Federal Register of December 12, 1990 (55 FR 51254), FDA 
issued a final rule that identified minimum AQLs for both patient 
examination and surgeons' gloves, and established the sample plans and 
test method for determining whether a lot of gloves were acceptable. 
This rule defined defects as ``leaks, tears, mold, embedded foreign 
objects, etc.'' The definitions, sampling plans, test methods, and 
adulteration levels identified in the

[[Page 15405]]

1990 Federal Register are currently codified in title 21 of the Code of 
Federal Regulations in Sec.  800.20.

II. Proposed Changes

A. Rationale and Summary of Changes

1. Continuing HIV/AIDS Incidence and Need for Protective Measures for 
Health Care Workers
    In a May 1998 report, CDC reaffirmed its expectation that health 
care workers should use medical gloves as an effective barrier to HIV, 
hepatitis B virus, and other blood-borne infections, and that these 
gloves should provide effective protection against exposure to 
pathogenic microorganisms in blood and other body fluids (Ref. 7).
    In the December 10, 1999, Morbidity and Mortality Weekly Report 
(MMWR), CDC estimated that the prevalence of HIV at the end of 1998 
ranged from 800,000 to 900,000 infected persons. CDC estimated that, of 
these 800,000 to 900,000 persons, HIV infection or AIDS was diagnosed 
in approximately 625,000 of the individuals (Ref. 8). In a fact sheet 
posted on the Internet in June 1999, CDC reported that 54 documented 
cases of HIV seroconversion resulted from occupational exposure to HIV 
(Ref. 9). In April 2002, CDC reported that, as of December 31, 1999, 
22,218 out of 437,407 adults reported diagnosed with AIDS were health 
care workers (Ref. 10). FDA concluded that medical gloves play an 
important role in the prevention of infectious disease transmission in 
health care settings, and that lowering the acceptable level of defects 
is necessary to further reduce the risk of transmission of such 
diseases and to harmonize the quality of gloves sold in the United 
States with international consensus standards.
2. Harmonization With Consensus Standards
    Following the publication of Sec.  800.20, several consensus 
standards organizations, such as the ISO and the ASTM, adopted the FDA 
test methodology and acceptance criteria for patient examination and 
surgeons' gloves. As glove manufacturing capabilities improved, these 
consensus standards organizations lowered the minimum acceptance 
criteria for holes/leaks for these gloves. In 1994, ISO published 
standards for surgeons' and patient examination gloves with AQLs of 1.5 
and 2.5, respectively. ASTM adopted these same acceptance criteria in 
April 1998, and March 1999, for surgeons' and patient examination 
gloves, respectively. Because the standards organizations updated their 
standards to reflect the improvement in manufacturing technology, the 
consensus standards currently have lower AQLs for medical gloves than 
FDA's regulation (Sec.  800.20).
    The consensus standards differ from the current FDA regulation in 
two other respects: (1) They use metric units for specifying 
dimensions, and (2) they refer to sampling plans from the ISO's 
document ISO 2859, ``Sampling Procedures for Inspection by 
Attributes,'' instead of the MIL-STD-105E sampling plan that is 
currently referenced in Sec.  800.20.
    FDA believes that, whenever feasible, it is important to harmonize 
its requirements with consensus standards. Harmonization helps ensure 
an acceptable standard of safety and effectiveness for all 
manufacturers and allows manufacturers to market their products more 
efficiently in a global economy. FDA has recognized the ASTM standards 
for patient examination and surgeons' gloves for the purpose of 
premarket notification submissions (510(k)s), and believes that it is 
appropriate to use the same standards for determining the acceptability 
of lots of medical gloves.
3. Interpretation of Defects
    Since issuing Sec.  800.20, FDA has received many questions from 
FDA field laboratories, glove manufacturers, importers, and private 
laboratories regarding the definition of defects in the current 
regulation. Many questions concerned whether lumps of latex material on 
or beneath the glove surface are considered defects. These questions 
arise because the definition of defects in Sec.  800.20 refers to 
``embedded foreign objects,'' and latex is not ``foreign'' to a latex 
glove. Other questions were whether ``mold'' is an appropriate defect 
to be included in a sampling plan intended primarily to detect physical 
defects. FDA believes these questions are valid and has addressed them 
in the proposed amendments.
4. Tightened Sampling Plans for Reconditioned Gloves
    FDA recognizes the difficulty of adequately representing a large 
lot of gloves with a relatively small sample size. FDA has sometimes 
allowed manufacturers and importers to segregate and retest portions of 
the lot(s) or sizes of reconditioned gloves that initially failed FDA 
or private laboratory analysis to identify those portions of the larger 
lot(s) or sizes that meet quality requirements. The agency recognizes, 
however, that passing a retest does not provide the same assurance of 
quality as when the lot passes the initial analysis. This is due, in 
part, to the nature of the standard sampling plans, and in part to the 
fact that retesting is performed to identify acceptable portions of the 
larger lot(s) after failing the initial test. Recognized consensus 
standard sampling plans address the issue of previous test failures by 
allowing tightened sampling during retesting in order to provide 
additional assurance to the consumer. FDA proposes to apply this 
principle to testing of reconditioned lots that have failed an initial 
analysis.
5. Proposed Reclassification of Medical Gloves
    On July 30, 1999, FDA published a proposed rule in the Federal 
Register (64 FR 41710) that addressed several issues pertaining to 
medical examination gloves, including their reclassification from class 
I to class II in order to provide reasonable assurance of safety and 
effectiveness. To provide this assurance, appropriate special controls 
(applicable to class II medical devices) were also proposed. The 
proposal to reclassify medical examination gloves reflects the 
increased importance of these devices in the health care arena and is 
consistent with the changes FDA is now proposing for Sec.  800.20. 
However, this proposal to lower the acceptable level of defects in 
medical gloves is an independent initiative that will go forward as FDA 
continues to review the comments it received on the reclassification 
proposal.
    Therefore, in summary, FDA is proposing to: (1) Lower the AQL to 
which the level of defects in lots of gloves is tested, thereby 
assuring improved quality of gloves; (2) lower the AQLs, convert units 
of measure to the metric system; eliminate references to obsolete 
sampling plans, and reference current ISO standards; thereby 
harmonizing with recognized consensus standards; (3) clarify visual 
defects and current methodology for conducting water leak testing; and 
(4) provide tightened sampling plans for testing reconditioned lots of 
medical gloves that have already failed one analysis.
    Specifically, FDA is proposing to lower the AQL for surgeons' 
gloves from 2.5 to 1.5, and is proposing to base the sampling plans on 
the tables in the ISO sampling standard, ISO 2859-1995.
    FDA is also proposing to lower the AQL for patient examination 
gloves from 4.0 to 2.5, and is proposing to base the sampling plans on 
the tables in ISO sampling standard, ISO 2859-1995. Lowering the AQLs 
for medical gloves will reduce the allowable defect level for patient 
examination gloves. Further, FDA is proposing to amend the regulation 
to tighten sampling plans for reconditioned lots of medical gloves

[[Page 15406]]

that have failed to meet the 1.5 or 2.5 AQL level. These reconditioned 
gloves would have to be sampled under a more stringent inspection 
standard in order to provide additional assurance that they meet the 
AQLs. This practice is consistent with the ISO sampling plans, which 
allow for tightened sampling when failures occur under normal sampling.

B. Paragraph by Paragraph Changes

1. Current Test Method (Sec.  800.20(b)) as Proposed General Test 
Method (Sec.  800.20(b)(1))
    (Change 1) FDA proposes to rename and renumber current Sec.  
800.20(b), Test method as Sec.  800.20(b)(1), General test method. FDA 
is revising the substance of the first sentence of current paragraph 
(b) to add the following language: ``For the purposes of this 
regulation, FDA's analysis of gloves for leaks, and certain other 
visual defects, will be conducted by an initial visual examination and 
by a water leak test method, using 1,000 milliliters (ml) of water.'' 
The purpose of these changes is to recognize that there are other 
visual defects addition to leaks, and that these defects can sometimes 
be detected by visual examination.
    (Change 2) For clarification, FDA would reorganize the remaining 
elements of current paragraph (b) into paragraphs (b)(1)(i) through 
(b)(1)(iii) of proposed Sec.  800.20(b)(1), as follows:
    [sbull] The current second and third sentences would be 
reorganized, without revision, in proposed Sec.  800.20(b)(1)(i), Units 
examined.
    [sbull] The current fifth, sixth, and seventh sentences would be 
reorganized and revised in proposed Sec.  800.20(b)(1)(ii), 
Identification of defects.
    [sbull] The current fourth sentence would be revised and 
reorganized, together with the current seventh and eighth sentences, in 
proposed Sec.  800.20(b)(1)(iii).
    (Change 3) Proposed Sec.  800.20(b)(1)(ii) changes the definition 
of defects from the current ``leaks, tears, mold, embedded foreign 
objects, etc.'' to ``tears, embedded foreign objects, or other defects 
visible upon initial examination that may affect the barrier integrity 
or leaks detected when tested in accordance with paragraph (b)(3) of 
this section.''
    FDA is proposing to remove ``mold'' as a defect in proposed Sec.  
800.20(b)(1)(ii). The agency considers the presence of visible mold on 
sampled gloves as evidence that the lot is adulterated under section 
501(a) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 
351(a)), in that it consists in whole and/or in part of any filthy, 
putrid, or decomposed substance. The revised section removes the 
abbreviation, ``etc.'', as being indeterminate.
    The phrase, ``other defects visible upon initial examination that 
may affect the barrier integrity,'' would be added in proposed Sec.  
800.20(b)(1)(ii), to encompass various other defects that may arise, 
including, but not limited to:
    a. Extrusions of glove material on the exterior or interior surface 
of, or within, the film of the glove. FDA believes that such extrusions 
or material lumps can contribute to rips or tears near the site of the 
lump, during routine donning or other stretching of the glove.
    b. Gloves that are fused together so that individual glove 
separation is impossible.
    c. Gloves that adhere to each other and tear when separated into 
individual gloves.
    (Change 4) In proposed Sec.  800.20(b)(1)(iii), the fourth sentence 
in current paragraph (b) would be revised and reorganized into two 
sentences for clarity, reading, ``One defect in one glove is counted as 
one defect. A defect in both gloves in a pair is counted as two 
defects.'' Other proposed changes to Sec.  800.20(b)(1)(iii) include:
    [sbull] To confirm current counting practices, FDA would add the 
clarifying sentence, ``If multiple defects, as defined in paragraph 
(b)(1)(ii) of this section, are found in one glove, they are counted as 
one defect.''
    [sbull] For further clarification, FDA is adding the sentence, 
``Visual defects and leaks that are observed in the top 40 millimeters 
(mm) of a glove will not be counted as a defect for the purposes of 
this part.'' The substance of this sentence is in current Sec.  
800.20(b)(2); however, FDA is changing the unit of measure, 1 1/2 
inches, to the corresponding metric unit of measure, 40 millimeters 
(mm), used by most standards setting organizations.
2. Current Untitled (Sec.  800.20(b)(1)) as Proposed Leak Test 
Materials (Sec.  800.20(b)(2))
    (Change 5) FDA proposes to rename current Sec.  800.20(b)(1) as 
proposed Sec.  800.20(b)(2), Leak test materials. To conform current 
U.S. measurement units to metric measurement units used by most 
standards setting organizations, FDA proposes to change the current 
language, ``2 3/8 inch by 15-inch'' to ``60 mm by 380 mm'' and ``11 
pounds'' to ``5 kilograms (kg).'' No other change would be made to 
current Sec.  800.20(b)(1).
3. Current Untitled (Sec.  800.20(b)(2)) as Proposed Visual Defects and 
Leak Test Procedure, Visual Defects Examination, and Leak Test Set-Up 
(Sec.  800.20(b)(3)(i) through (b)(3)(ii))
    (Change 6) FDA is proposing to renumber and revise current Sec.  
800.20(b)(2) into the following new paragraphs:
    [sbull] (b)(3) Visual defects and leak test procedures.
    [sbull] (b)(3)(i) Visual defects examination.
    [sbull] (b)(3)(ii) Leak test set-up.
    (Change 7) FDA is also proposing to revise current Sec.  
800.20(b)(2) in proposed paragraph (b)(3) to reorganize the section for 
clarity to read, ``(3) Visual defects and leak test procedures. Examine 
the sample and identify code/lot number, size, and brand as 
appropriate. Continue the visual examination using the following 
procedures:''.
    (Change 8) FDA is also proposing to revise current Sec.  
800.20(b)(2) in proposed paragraph (b)(3)(i) to incorporate metric 
units of measure, reflecting the harmonization of the test method to 
international standards. The revisions would read as follows:
    (i) Visual defects examination. Inspect the gloves for visual 
defects by carefully removing the glove from the wrapper, box, or 
package. Visually examine each glove for defects. As noted in 
paragraph (b)(1)(iii) of this section, a visual defect observed in 
the top 40 mm of a glove will not be counted as a defect for the 
purpose of this part. Visually defective gloves do not require 
further testing; however, they must be included in the total number 
of defective gloves counted for the sample.
    (Change 9) In proposed Sec.  800.20(b)(3)(i) in the third sentence, 
``1 1/2 inches'' would be changed to ``40 mm'', to reflect the 
corresponding metric unit of measure used by most standards setting 
organizations.
    (Change 10) FDA proposes to add the following statement to Sec.  
800.20(b)(3)(ii) Leak test set up, ``During this procedure, ensure that 
the exterior of the glove remains dry.'' This method conforms to the 
``Standard Test Method for Detection of Holes in Medical Gloves'' found 
in ASTM D5151. The reason for including this step is that a leak can be 
detected more easily on a dry surface.
    (Change 11) For ease of reading, FDA is proposing to reorganize 
current Sec.  800.20(b)(3) into three paragraphs in proposed 
(b)(3)(iii) Leak test examination. The first three current sentences 
would be in the first paragraph, the current fourth sentence would be 
in the second paragraph, and the remaining three current sentences 
would be in the third paragraph.

[[Page 15407]]

4. Current Sample Plan (Sec.  800.20(c)) as Proposed Sampling, 
Inspection, Acceptance, and Adulteration (Sec.  800.20(c))
    (Change 12) FDA is proposing to rename current paragraph Sec.  
800.20(c) paragraph, ``(c) Sampling, inspection, acceptance, and 
adulteration,'' and to reorganize the section as follows:
    [sbull] (c)(1) Sample plans.
    [sbull] (c)(2) Sample sizes, inspection levels, and minimum AQLs.
    [sbull] (c)(3) Adulteration levels and accept/reject criteria.
    (Change 13) Proposed introductory paragraph Sec.  800.20(c) would 
retain the element of current paragraph (c), which identifies how FDA 
will sample and examine lots of gloves to determine whether the gloves 
are considered adulterated under section 501(c) of the act. Proposed 
paragraph Sec.  800.20(c) would be revised as follows: ``(c) Sampling, 
inspection, acceptance, and adulteration. In performing the test for 
leaks and other visual defects described in paragraph (b) of this 
section, FDA will collect and inspect samples of medical gloves, and 
determine when the gloves are acceptable as set out in paragraphs 
(c)(1) through (c)(3) of this section.''
    (Change 14) Proposed Sec.  800.20(c)(1) retains the elements of 
current paragraph (c) that identify the sampling plans, inspection, and 
AQLs used by the agency in its determination of adulteration. In Sec.  
800.20(c)(1), FDA is proposing to change the standard of sampling 
procedures and inspection tables from ``MIL-STD-105E'' to ``ISO 2859'' 
because ``MIL-STD-105E'' is no longer in effect. The use of ISO 2859 is 
consistent with the agency's recognition of this standard as provided 
in section 514 of the act (21 U.S.C. 360d) (see FDA's Internet Web site 
at http://www.fda.gov/cdrh/stdsprog.html).
    (Change 15) Proposed Sec.  800.20(c)(2) retains the same ``single 
normal sampling,'' ``multiple normal sampling,'' and ``general 
inspection level II'' that are in current paragraph (c). In proposed 
paragraph (c)(2), FDA proposes lowering the minimum AQL for surgeons' 
gloves from the current 2.5 AQL to a 1.5 AQL. Additionally, FDA 
proposes to lower the minimum AQL for patient examination gloves from a 
4.0 AQL to a 2.5 AQL. These changes would reduce the allowable level of 
defective gloves in sampled lots of medical gloves and harmonize FDA 
adulteration criteria with the recognized consensus standards for 
medical gloves.
    (Change 16) FDA is proposing to remove the current table entitled 
``ADULTERATION LEVEL AT 2.5 FOR SURGEONS' GLOVES'' and the current 
table entitled ``ADULTERATION LEVEL AT 4.0 FOR PATIENT EXAMINATION 
GLOVES,'' and replace them with the table entitled ``ACCEPT/REJECT 
CRITERIA AT 1.5 AQL FOR SURGEONS' GLOVES'' and the table entitled, 
``ACCEPT/REJECT CRITERIA AT 2.5 AQL FOR PATIENT EXAMINATION GLOVES,'' 
following proposed Sec.  800.20(c)(3).
5. Current Untitled (Sec.  800.20(d)) as Proposed Compliance (Sec.  
800.20(d))
    (Change 17) For purposes of clarification, FDA is proposing to 
revise Sec.  800.20(d) as follows:
    [sbull] (d) Compliance.
    [sbull] Add (d)(1) Detention and seizure,
    [sbull] Add (d)(2) Reconditioning,
    [sbull] Add (d)(2)(i) Modified sampling, inspection, and 
acceptance,
    [sbull] Add (d)(2)(ii) Adulteration levels and acceptance criteria, 
and adulteration levels for reconditioned gloves; and
    [sbull] Add tables, ``ACCEPT/REJECT CRITERIA AT 1.5 AQL FOR 
RECONDITIONED SURGEONS' GLOVES'' and ``ACCEPT/REJECT CRITERIA AT 2.5 
AQL FOR RECONDITIONED PATIENT EXAMINATION GLOVES'', following paragraph 
(d)(2)(ii).
    (Change 18) Proposed introductory Sec.  800.20(d) retains the 
regulatory element of current paragraph (d), which establishes that 
medical gloves that are ``rejected,'' i.e., fail to meet acceptance 
criteria in proposed Sec.  800.20(c)(3) when tested as described in 
proposed Sec.  800.20(b), are adulterated in accordance with section 
501(c) of the act.
    (Change 19) Detention under section 801(a) of the act (21 U.S.C. 
381(a)) and seizure under section 304(b) of the act (21 U.S.C. 334(b)) 
are common administrative or enforcement actions FDA has taken against 
medical gloves that are in violation of section 501(c) of the act. FDA 
may detain and refuse entry to medical gloves that are presented for 
import and found to be adulterated under section 501(c) of the act. 
Medical gloves found to be adulterated while in domestic interstate 
commerce are subject to seizure. Agency regulatory procedures for the 
reconditioning of domestically manufactured gloves seized in interstate 
commerce are found in the FDA/ORA (Office of Regulatory Affairs) 
Regulatory Procedures Manual (RPM), Chapter 6 Judicial Actions, 
Subchapter--Seizure, Disposition of Seized Articles, Reconditioning 
Operations. Regulatory procedures for detained imported gloves are in 
RPM Chapter 9 Import Operations/Actions, Subchapter--Reconditioning. 
When appropriate, FDA may take other regulatory actions, such as 
injunction, civil money penalties, or criminal prosecution of 
manufacturers and individuals responsible for adulterated products. FDA 
is proposing to add revised Sec.  800.20(d)(1) to include the detention 
and seizure of gloves that are adulterated under section 501(c) of the 
act because the quality falls below the level it is represented to 
have. Under the authority of section 801(b) of the act for imported 
gloves and section 304(d)(1) of the act for seized domestic articles, 
FDA is proposing to add revised Sec.  800.20(d)(2) to provide the 
importer of record, owner, or consignee an opportunity to recondition 
the gloves as a lot or part of a lot, whether they are foreign or 
domestic gloves.
    (Change 20) In Sec.  800.20(d)(2)(i), FDA is proposing a modified 
sampling plan. The rationale for the plan is based on the agency's 
experience with reconditioned gloves, the need for greater assurance 
that reconditioned gloves meet minimum AQLs given the initial finding 
of adulteration, and the provisions in ISO 2859 for tightened sampling 
plans.
    FDA samples medical gloves that are often presented for import in 
large quantities. When the ``sampling lots'' are large and include 
several glove sizes and manufacturing lots, FDA attempts to have each 
sample adequately represent each size in the proportion it occurs in 
the ``sampling lot.'' On occasion, manufacturers and importers have 
claimed that a single size or lot code may have contributed to a 
disproportionate number of defects that caused the sample to fail, and 
have requested FDA to allow the rest of the shipment to be salvaged, 
based on retesting of each of the segregated sizes or lot codes. Such 
segregation and retesting is considered reconditioning.
    FDA district offices review reconditioning proposals on a case by 
case basis. In determining, whether to approve a reconditioning 
proposal, the district offices exercise discretion in considering the 
nature and type of defects, the degree of noncompliance with minimum 
AQLs, the compliance history of the manufacturer, the qualifications 
and reliability of the independent testing laboratories, and any other 
relevant factors.
    When FDA has permitted manufacturers/importers of gloves that have 
failed FDA or private laboratory analysis to segregate and retest 
portions of the lot(s)/size(s), the agency's experience has been that 
the segregated lot(s)/sizes(s) almost always pass the retest, resulting 
in two contradictory

[[Page 15408]]

conclusions about the analyzed lot. Statistically, a passing retest 
result is not unexpected due to the nature of the normal sampling 
plans, which minimize producer risk. When failures occur under normal 
sampling, ISO 2859 recommends the use of tightened sampling plans for 
resubmitted lots in order to reduce the risk to the consumer (see part 
1 section 7.4 of ISO 2859). FDA is proposing that single normal 
sampling plans and the tightened level of inspection, found in ISO 
2859, be used in resampling and retesting medical gloves that have been 
reconditioned. The proposed modifications would increase the size of 
the sample and the number of units examined, while lowering the number 
of defects required for rejection. FDA believes that this would provide 
greater statistical assurance that reconditioned lots meet minimum 
AQLs.
    (Change 21) FDA proposes to add Sec.  800.20(d)(2)(ii) to establish 
accept/reject criteria and adulteration levels for reconditioned 
surgeons' gloves and patient examination gloves based on the tightened 
sampling plans proposed in paragraph (d)(2)(i). For convenience, FDA is 
adding tables following Sec.  800.20(d)(2)(ii), which describe the 
number of units to examine and the accept/reject criteria for various 
lot sizes.

III. Environmental Impact

    The agency has determined under 21 CFR 25.30(i) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

IV. Analysis of Impacts

A. Introduction

    FDA has examined the proposed rule under Executive Order 12866 and 
the Regulatory Flexibility Act (5 U.S.C. 601-612) (as amended by 
subtitle D of the Small Business Regulatory Enforcement Fairness Act of 
1996 (Public Law 104-121)), and the Unfunded Mandates Reform Act of 
1995 (Public Law 104-4). Executive Order 12866 directs agencies to 
assess all costs and benefits of available regulatory alternatives and, 
when regulation is necessary, to select regulatory approaches that 
maximize net benefits (including potential economic, environmental, 
public health and safety, distributive impacts and equity). Under the 
Regulatory Flexibility Act, if a regulation has a significant economic 
impact on a substantial number of small entities, the agency must 
analyze regulatory options that would minimize the impact on small 
entities. Section 202(a) of the Unfunded Mandates Reform Act requires 
that agencies prepare a written statement of anticipated costs and 
benefits before proposing any regulation that may result in expenditure 
by State, local, and tribal governments, or by the private sector of 
$100 million in any one year (adjusted annually for inflation). 
Currently, such a statement is required if costs exceed $110 million 
for any one year.
    The proposed regulation is consistent with the principles set forth 
in Executive Order 12866 and the two statutes. As explained in the 
following paragraphs, FDA does not believe the proposed regulation is a 
significant regulatory action, as defined in Executive Order 12866. In 
addition, FDA certifies under the Regulatory Flexibility Act that the 
proposed regulation would not result in a significant economic impact 
on a substantial number of small entities. The expected cost of this 
proposed regulation is under $110 million in any one year and is 
therefore not considered a major regulatory action as defined by the 
Unfunded Mandates Reform Act.

B. Objective of the Proposed Regulation

    The objective of the proposed regulation is to reduce the risk of 
transmission of blood-borne pathogens (particularly HIV and hepatitis B 
(HBV) and C (HBC) infections). The regulation would accomplish this 
objective by ensuring that medical gloves (surgeons' and patient 
examination gloves) maintain a high level of quality with respect to 
the level of noted defects. By so doing, FDA also would harmonize its 
standard for acceptable defects with consensus quality standards 
developed by ISO and ASTM.

C. Current Risks of Blood-Borne Illness

    Unnecessary exposures to blood-borne pathogens are of great 
importance to the health care community because contact with 
contaminated human blood or tissue products has led to increased cases 
of HIV, HBV, and HCV infections.
    Available data cannot precisely quantify the number of new HIV 
cases that this proposed rule would prevent. This analysis, however, 
attempts to derive a conservative estimate. For the year 2000, the CDC 
reported a cumulative total of approximately 900,000 persons in the 
United States who had contracted HIV, of which 775,000 cases had 
progressed to AIDS (Ref. 1). Of those patients whose conditions had 
progressed to AIDS, almost 450,000 (58 percent) had died as of December 
2000. For the year 2000, the CDC identified 21,704 new cases of HIV 
infection.
    Approximately 5 percent of the reported HIV/AIDS cases were among 
health care personnel (Ref. 2). However, in an indepth analysis of 
occupational risk, the CDC reported that, since 1992, there have been 
only 56 identified incidents of occupational transmission of the HIV 
pathogen and all but 7 of these cases (12.5 percent) were due to 
percutaneous cuts or needle sticks. In addition, there were 138 other 
cases of HIV infection or AIDS among health care workers with 
occupational exposures to blood who had not reported other risk factors 
for HIV infection (Ref. 2). Assuming the same 12.5 percent rate for 
these workers implies that 17 additional cases of HIV transmission to 
health care personnel during this period might have been caused by 
cutaneous contact in an occupational setting. Consequently, a total of 
24 incidents of occupational transmission of HIV to health care 
personnel may have occurred over the 10-year period (or 2.4 per year) 
due to problems with the glove barrier protection properties of gloves 
used in health care settings.
    The CDC also reports approximately 80,000 new cases of HBV for the 
latest available reporting period (1999) (Ref. 3). There are 
approximately 1.25 million people in the United States chronically 
infected with HBV. While only 6 percent of those who contract HBV after 
the age of 5 will develop chronic conditions, 15 to 25 percent of those 
that do will die prematurely. Health care personnel are at some risk of 
this pathogen, but the availability of a vaccine has reduced the risk 
of negative outcomes due to exposure.
    FDA has no direct data for estimating the rate of new HBV 
infections in health care personnel. While the CDC has reported the 
risk to health care workers as ``low,'' there is no definition of that 
term (Refs. 3 and 4). FDA estimates that as many as 4,000, or 5 
percent, of all new incidents of HBV occur in health care personnel. 
Because occupational transmission of HBV may be approximately 5 times 
more likely than for HIV, FDA imputes approximately 140 annual cases of 
occupational transmission of HBV to health care personnel. (HIV rate of 
7.3 /1,085 x 5 x 4,000.) CDC analyses have stated that ``most'' of the 
occupational transmissions are due to percutaneous injuries (cuts) 
(Ref. 4). Because 2.4 of the 7.3 annual HIV cutaneous contact 
transmissions (33 percent) were believed to be attributable to glove 
defects, FDA similarly expects that

[[Page 15409]]

about one-third of the 140 annual occupational transmissions of HBV 
infections (approximately 40 cases) may potentially be associated with 
the current quality level of medical gloves. If only 6 percent of these 
cases develop chronic conditions, then an average of 2.4 annual cases 
of chronic HBV are associated with defective medical gloves.
    HBV currently infects 3.9 million persons (Ref. 3). Over 2.7 
million patients have reported chronic conditions. More than 40,000 new 
cases were reported during 1999. The risk of exposure to health care 
workers, however, appears to be extremely low. In fact, according to 
the CDC, for other than needle stick punctures, no transmission of HCV 
for health care personnel has been documented from intact or no intact 
skin exposures to blood or other fluids or tissues (Ref. 4). Thus, 
there is little evidence that glove defects are associated with HCV 
exposures.
    As a result, FDA estimates the overall annual transmission of 
blood-borne pathogens due to defects in glove barrier protection in 
health care settings to include 2.4 cases of HIV infection and 2.4 
cases of HBV infection. Increasing the AQL of gloves by lowering the 
rate of acceptable defects would reduce the transmission rates of these 
pathogens.

D. Baseline Conditions

    The current AQL for medical gloves allows a defect rate of 4.0 
percent (0.04) for patient examination gloves and 2.5 percent (0.025) 
for surgeons' gloves. The AQL represents the proportion of sampled 
gloves from a given lot that may include defects such as leaks or 
foreign material and still be accepted for entry into the marketplace. 
Currently, if more than 4 percent of the sampled patient examination 
gloves exhibit defects, the entire lot of gloves may not be sold as 
medical devices. Surgeons' gloves are sampled to a higher quality level 
(the lower AQL requires a higher proportion of nondefective gloves in 
order to pass inspection), because these products have a higher 
likelihood of contact with bodily fluids. Of course, medical glove lots 
that fail to meet the AQL may be marketed as household or other 
products. If a sample of gloves fails to meet the AQL, the marketer may 
petition for resampling of the lot. The required resampling plan for a 
lot originally found to be out of compliance is more intensive than the 
original sampling plan for a randomly selected lot. Lots initially 
found to be out of compliance are either resampled and subsequently 
offered as medical gloves after meeting the current AQL, offered as 
nonmedical gloves, or sold in foreign markets.
    Approximately 30.8 billion medical gloves were sold in the United 
States during the year 2000 (Ref. 6). According to FDA records, there 
are 417 manufacturers of medical gloves. Of these, only six are 
domestic firms. Malaysian manufacturers supply almost 44 percent of the 
medical gloves in the United States (Ref. 7). Only 250 million surgical 
gloves are imported each year (0.8 percent of the medical glove market) 
and the impact on this sector is negligibly different from overall 
patient examination gloves. Therefore, this analysis focuses 
exclusively on patient examination gloves.
    FDA expects the demand for medical gloves to increase by the same 
rate as employment in the medical services industry. The Bureau of 
Labor Statistics (BLS) projects annual employment growth of 2.6 percent 
for this industry (NAICS 6200) (Ref. 8), which implies an annual demand 
for almost 40 billion medical gloves within 10 years. (A 2.6 percent 
annual growth rate results in an expected increase of 29.3 percent in 
10 years).
    Medical glove lot sizes may vary from as few as 25 gloves to as 
many as 500,000. According to discussions with manufacturers (Eastern 
Research Group, Inc. (ERG); 2001), a typical production or import lot 
from a foreign manufacturer contains an average of 325,000 gloves 
(either patient examination or surgeons'). This implies that the U.S. 
medical glove market currently imports about 95,000 lots of gloves per 
year. FDA currently samples only about 1.5 percent (0.015) of all glove 
lots, or 1,400 lots per year. Within 10 years, FDA expects the number 
of lots offered for import to increase to 122,500 per year. If the 
compliance sampling rate remains constant, FDA would sample 1,850 lots 
during that year.
    FDA's Winchester Engineering and Analysis Center (WEAC) analyzed 
results from samples collected from 2000 and 2001. These samples 
represent approximately one-third of FDA's total sampling effort for 
that period. A total of 98,067 gloves were tested from 942 separate 
lots. Of these gloves, 2,354 (0.024) were defective, which implies that 
2.4 percent of marketed gloves are likely to be defective. If so, then 
approximately 740 million defective medical gloves are currently 
marketed (30.8 billion gloves x 0.024). At the current AQL of 4.0 
percent, 28 lots failed (0.0297) the WEAC analysis. Consequently, 
approximately 42 of the annually sampled lots are defective (1,400 x 
0.0297). By the 10th year, in the absence of the proposed regulation, 
955 million defective gloves would be marketed and 55 percent of the 
sampled lots would fail to meet the AQL.
    FDA allows glove lots that fail to meet the AQL to be resampled. 
Sponsors usually attempt to resample the glove lot rather than divert 
the entire lot to alternative markets. According to discussions with 
industry sources and testing laboratories, the cost of domestic lot 
resembling and retesting for leakage and tensile strength equals 
approximately $1,400. The current annual industry cost of resampling 
glove lot failures with the current AQL, therefore, is approximately 
$59,000 (42 lots x $1,400 per lot). This resampling and retesting cost 
would equal $77,000 within 10 years.

E. Costs of the Proposed Regulation

    FDA expects that the proposed regulation would result in changed 
shipping practices by medical glove manufacturers. Currently, 
manufacturers use the target AQLs as a guide for releasing production 
lots of gloves for export to the United States because the release 
criteria are lower in the United States. Manufacturers attempt to avoid 
having three lot inspection failures within a 24-month period, because 
this results in rejection of future imports under FDA's current 
recidivist policy. Thus, to maintain an uninterrupted supply of gloves 
to customers, and to guard brand loyalty while avoiding the recidivist 
list, manufacturers would be expected to raise their level of quality 
control to at least maintain the current average lot rejection rate of 
2.97 percent. FDA also expects the regulation to increase the costs of 
sampling by requiring larger and more detailed sampling plans to assure 
that the lower AQL is met for each inspected glove lot. FDA does not 
envision increased regulatory oversight costs because the number of 
inspections is not expected to change.
1. Costs of Quality Control
    Manufacturers currently conduct quality control tests on glove lots 
prior to release. These tests include water-tight leak and tensile 
strength assays. According to interviews with glove manufacturers, the 
current cost of conducting these tests at the manufacturing site is 
approximately $310 per lot, whereas more stringent quality control 
testing may cost an additional $45 per lot. The additional cost is for 
increased inventory and larger sample sizes to ensure more precise 
measurements at the lower AQL. Because approximately 95,000 lots of 
medical gloves are imported per year,

[[Page 15410]]

the expected costs are $4.3 million (95,000 lots x $45 per lot). Due to 
the expected increase in the demand for medical gloves by the 10th 
evaluation year, the compliance cost of meeting this increased quality 
level will equal $5.5 million. Over the 10-year period, the average 
annualized cost of this increased level of testing (at a 7 percent 
discount rate) is $4.9 million.
2. Increased Sampling Costs
    A lower AQL would result in increased sampling costs for imported 
glove lots. The increased sampling costs would result from the need to 
test greater quantities of gloves to ensure sufficient statistical 
power. Based on reported costs from U.S. testing laboratories, ERG, an 
independent economic contractor, estimated that increased testing would 
add approximately $200 to the current costs of $1,400 per sample. (The 
difference between this increased cost and the $310 increased import 
sampling cost is attributable to lower costs in the foreign countries 
that produce medical gloves.) FDA currently samples about 1.5 percent 
of the 95,000 annual imported lots, or 1,400 samples. Thus, the 
increased sampling costs due to the proposal are $0.3 million ($1,400 x 
$200). Within 10 years, this increased cost will equal $0.4 million 
(due to expected increases in the number of inspected glove lots) and 
the average annualized sampling cost (at a 7 percent discount rate) 
increase is $0.3 million.
3. Withheld Lots
    In addition, the proposed AQL is likely to result in an increase in 
the number of lots of medical gloves that are not released for shipment 
to the U.S. medical market. For example, manufacturers may attempt to 
maintain a target compliance level in order to avoid FDA's recidivist 
listing. FDA's WEAC research laboratory sampled 942 lots and discovered 
that 28 failed using the current AQL while 79 lots failed using the 
proposed AQL. To maintain the original 0.0297 (28/942) lot failure 
rate, the 53 lots with the highest defect rate would have to be held 
back by the affected manufacturers (.056)\1\. Therefore, FDA expects, 
that under the proposed AQL, approximately 5,500 lots would be held 
back by manufacturers. In order to meet the expected demand in 10 
years, 7,000 lots would be held back. FDA believes that glove lots that 
fail to meet the proposed AQL medical quality standards would most 
likely be sold as nonmedical gloves. Manufacturers and distributors 
would experience some loss of revenue from this shift, because of the 
price premium commanded by medical gloves. FDA believes this loss would 
be inconsequential.
---------------------------------------------------------------------------

    \1\ The current lot failure rate (28/942=0.0297) is reached by 
removing 53 defective lots from the sample. If only the 51 
additional failing lots are removed, the overall failure rate is 
0.0314 (28/891). The expected future failure rate is 0.0292 (26/
889). FDA expects the withheld lots to include those with the 
highest defect rates.
---------------------------------------------------------------------------

4. Costs of FDA Inspections
    FDA does not envision increased inspection costs due to the 
proposed regulation. The rate of sampled glove lots is not expected to 
change and FDA resources are not expected to increase over the 
evaluation period.
5. Total Costs
    In sum, therefore, FDA estimates that the proposed regulation would 
have an average annualized cost of about $5.2 million.

F. Benefits of the Proposed Regulation

    The proposed regulation would result in public health gains by 
reducing the frequency of blood-borne pathogen transmissions due to 
defects in the barrier protection provided by medical gloves. Based on 
an implied societal willingness to pay (WTP), an annualized monetary 
benefit of $12.3 million would be saved due to fewer pathogen 
transmissions and unnecessary blood screens. Moreover, fewer glove 
defects would reduce the number of, and, therefore, the cost and 
anxiety associated with, unnecessary blood screens (i.e., those that 
yield negative results for health care personnel).
1. Reductions in Marketed Defective Gloves
    As noted in the previous paragraphs, FDA finds that approximately 
740 million defective gloves are marketed each year in the United 
States, or 2.4 percent of all medical gloves. In the absence of this 
regulation, FDA expects that the number of defective medical gloves 
marketed in the United States each year would increase to 955 million 
gloves within 10 years. The proposed regulation would substantially 
reduce this figure.
    WEAC's analysis of 98,067 medical gloves from 942 sampled lots 
collected in 2000 and 2001 resulted in approximately 3 percent lot 
failures under the current AQL of 4 percent (28 failed lots). This lot 
failure rate was associated with 2,356 defective gloves, or 2.4 percent 
of the total number of sampled gloves. Under the proposed AQL of 2.5 
percent, the WEAC analysis concluded that 51 additional lots would fail 
(a total of 79 failed lots), increasing the lot failure rate from 2.97 
percent to 8.39 percent.
    As discussed earlier, FDA maintains a recidivist policy under which 
manufacturers are denied import entry if three lots fail statistical 
sampling within a 24-month period. To avoid the denial of entry, 
manufacturers may be expected to hold a sufficient number of defective 
lots from shipment in order to maintain the same target lot failure 
rate (approximately 3 percent) with a new AQL. For example, removing 
the 53 most defective lots in the testing sample would result in 26 lot 
failures from 889 total lots, thereby maintaining the original 2.92 
percent lot failure rate. This scenario leaves 85,172 total gloves in 
the sample, of which 1,512 gloves were defective, resulting in a glove 
defect rate of 1.78 percent. The proposed regulation, therefore, could 
reduce the proportion of marketed defective medical gloves from 2.4 
percent of all marketed gloves to 1.78 percent of all marketed gloves.
    The implications of this expected reduction in defective gloves are 
significant. The current AQL is associated with 740 million glove 
defects in the present year and within 10 years would result in 955 
million annually marketed defective medical gloves. If the proposed AQL 
were in place, the current annual number of defective gloves would 
approximate 548 million and within 10 years would reach 709 million. 
The number of defective gloves, therefore, would be reduced by more 
than 25 percent due to the new AQL.
2. Reductions in Blood-Borne Pathogens
    FDA has estimated that, on average, there are potentially 4.8 
annual transmissions of blood-borne pathogens associated with medical 
glove defects (section IV.C of this document). These transmissions 
include 2.4 cases of HIV and 2.4 cases of chronic HBV. Because there 
are currently no documented cases of cutaneous transmission of HCV that 
would be affected by improving glove quality levels, this analysis does 
not consider potential HCV cases.
    a. Reductions in HIV transmission. While the direct relationship 
between defective medical gloves and HIV is unknown, FDA believes it is 
reasonable to apply the proportional reduction in the number of 
defective gloves due to the proposed regulation (about 25 percent) to 
the annual transmission rate of the HIV pathogen to health care 
personnel. In the absence of this regulation, the current expectation 
of 2.4 annual cases of HIV transmission to health care personnel would 
likely increase to 3.1 annual cases within 10

[[Page 15411]]

years due to the expected growth of employment in the health services 
industry. However, if the proposed AQL were in place, FDA forecasts the 
expected value of the annual transmission of HIV in health care 
personnel to equal 1.8 cases during the first effective year and 2.3 
cases by the 10th year (based on the expected proportionate decrease in 
marketed defective gloves). Over the entire 10-year evaluation period, 
these assumptions suggest that the regulation would prevent 
approximately seven cases of HIV transmission to health care personnel.
    b. Reductions in HBV transmissions. Hepatitis B transmissions to 
health care personnel are more common than cutaneous HIV transmissions. 
However, little specific data are available to identify affected 
patient populations. FDA has estimated that as many as 2.4 cutaneous 
transmissions of chronic HBV may be due to defective medical gloves 
each year. In the absence of this rule, this number is expected to 
increase to 3.1 annual transmissions within 10 years, based on the 
expected employment growth in the health services industry.
    Implementation of the proposed regulation would decrease these 
transmissions by about 25 percent. Under the new standard, FDA expects 
1.8 HBV transmissions during the first evaluation year, a reduction of 
0.6 transmissions from baseline conditions. By the 10th evaluation 
year, FDA expects 2.3 chronic HBV transmissions under the proposed AQL, 
a total of 0.8 fewer cases. Overall, about seven transmissions of 
chronic HBV would be avoided due to the proposed regulation over a 10-
year period.
3. Reductions in the Number of Blood Screening Tests
    As the number of defective gloves marketed in the United States 
decreases due to this regulation, corresponding reductions would be 
expected in the number of unnecessary blood screens. FDA contacted 
several research hospitals to ascertain how frequently health care 
personnel identify glove failure as a reason for initiating blood 
screens. Respondents stated that about 5 percent of all glove failures 
are noticed by the user and about 1 percent of these identified 
failures are reported to the facility for additional screening (Refs. 9 
and 10). Respondents noted that the glove failure could occur prior to 
patient contact. The additional screening may apply to the affected 
health care personnel or the patient if identified. The great majority 
of these screens result in negative findings.
    As shown in the previous paragraphs, during the first evaluation 
year under the new rule, FDA projects the number of defective gloves 
marketed in the United States to decrease from 740 to 548 million, a 
reduction of 192 million defective gloves. By the 10th year, the annual 
number of defective gloves is expected to decrease from 955 to 709 
million, a reduction of 246 million defective gloves. At the rates of 
potential identification (5 percent) and reports of contact with 
pathogens (1 percent) obtained from the research hospital sector, the 
proposed regulation would result in 96,000 fewer unnecessary blood 
screens during the first year (192 million fewer defects x 0.05 x 
0.01). By the 10th year, 123,000 fewer annual blood screens are 
expected. Over the entire period, the regulation could result in 
1,095,000 fewer unnecessary blood screens.
4. Value of Avoiding Blood-Borne Pathogen Transmissions
    a. Quality adjusted life-years. The economic literature includes 
many attempts to quantify societal values of health. A widely cited 
methodology assesses wage differentials necessary to attract workers to 
riskier occupations. This research indicates that society is willing to 
pay approximately $5 million to avoid a statistical death (Refs. 11, 
12, and 13). That is, social values appear to show that people are 
willing to pay a significant number of dollars to reduce even a small 
risk of death; or similarly, to demand significant payments to accept 
even marginally higher risks.
    Because this estimate is predominantly based on blue-collar 
occupations that mainly attract males between the ages of 30 and 40, 
FDA adjusted the life-expectancy of a 35 year-old male to account for 
future bed and nonbed disability (Refs. 14, 15, and 16), and amortized 
the $5 million (at a 7 percent discount rate) over the resulting 
quality-adjusted life span. The result yields an estimate of $373,000 
per quality adjusted life-year (QALY), which implies that society is 
willing to pay $373,000 for the statistical probability of a year of 
perfect health.
    b. Value of morbidity losses. In theory, loss of health reduces the 
willingness to pay for additional longevity. Many studies have 
attempted to estimate the relative loss of health for different 
conditions of morbidity. One method utilizes the Kaplan-Bush Index of 
Well-Being. This index assigns relative weights to functional states, 
and then adjusts the resulting weighted value by the problem/symptom 
complex that contributed to loss of function (Refs. 16 and 17). 
Functional state is measured in three areas: Mobility, social activity, 
and physical activity. For example, with treatment, chronic HBV may not 
have a major impact on any of these functions; a patient could drive a 
car, walk without a physical problem, and participate in work, school, 
housework, and other activities. However, because a patient with HBV 
has an ongoing problem/symptom complex, the relative weight of this 
functional state is estimated at 0.7433.\2\
---------------------------------------------------------------------------

    \2\ Note: The implication is that an ideal health state is 
valued as 1.0000 and mortality at 0.0000.
---------------------------------------------------------------------------

    This methodology then adjusts the weighted value of the functional 
state by the most severe problem/symptom complex contributing to that 
state. In the case of HBV, the most common symptom is general 
tiredness, weakness, or weight loss. This complex has a derived 
relative weight of +0.0027, which when added to the weighted functional 
state value results in a relative weight of 0.7460. The loss of 
relative health due to HBV, therefore, is expected to equal 1.0000 
minus 0.7460, or 0.2540 of perfect health. When this relative health 
loss is applied to the derived value of a QALY, it implies that society 
is willing to pay $93,000 per year to avoid a case of HBV ($373,000 
times 0.2540). This value includes the potential costs of treatment and 
additional prevention, as well as any perceived pain and suffering.
    FDA compared this methodology to a variety of published estimates 
of preference ratings of morbidity prepared by the Harvard Center for 
Risk Analysis (HCRA) (Ref. 17a). The published ratings of 14 studies of 
chronic HBV ranged from 0.75 to 1.00 (no impact). While the estimate 
used in this analysis (0.746) is in the low end of the collected 
published studies, FDA notes that most of the expressed preferences 
that were derived from time trade-off and standard gamble methodologies 
as compared to author judgment were closer to the FDA estimate. A 
health care worker who may contract HBV may typically have a life 
expectancy of approximately 40 years (as of 2000, a 40-year old female 
has a future life expectancy of 41.1 years (Ref. 14)). The present 
value of $93,000 per year for 40 years at a 7 percent discount rate 
implies that society is willing to pay $1.24 million to avoid the 
statistical likelihood of a case of chronic HBV in health care 
personnel.
    Deriving society's implied WTP to avoid HIV is more complicated. 
The CDC has published data indicating that approximately 80 percent of 
all HIV infections progress to AIDS within 5 years. Of the cases of 
AIDS, over half

[[Page 15412]]

(approximately 60 percent) result in mortality within an additional 5 
years. Thus, for a 10 year period, FDA tracked three potential 
outcomes: Patients who contract HIV but do not progress to AIDS (20 
percent); patients who contract HIV and progress to AIDS in 5 years and 
survive (32 percent); and patients who contract HIV, progress to AIDS 
within 5 years, and then die within the next 5 years (48 percent).
    HIV infection may not affect either mobility or social activity. 
However, such an infection may somewhat inhibit physical activity. HIV 
patients are able to walk, but with some physical limitations. This 
functional state has a relative weight of 0.6769. The main problem/
symptom complex of HIV is general tiredness (as for HBV), so the 
selected functional weight is adjusted by +0.0027 to result in relative 
well-being of 0.6796. As a result, the relative societal willingness to 
pay to avoid the statistical probability of a case of HIV in health 
care personnel is estimated at approximately $120,000 per year 
($373,000 times [1.0000 minus 0.6796]). According to the collected 
preference scores (Ref. 17a) in the Car's Catalog of Preference Scores, 
the average estimated published preference rating for HIV infection was 
0.7 (range 0.3 to 1.00).
    If HIV progresses to AIDS, a patient's functional state is likely 
to be more restricted. An AIDS patient requires some assistance with 
transportation, is limited in physical activity, and is limited in 
work, school, or household activity. The relative weight for this 
functional state is 0.5402. The main problem/symptom of AIDS remains 
general tiredness and loss of weight (as with HIV and HBV), so the 
adjusted health state is 0.5429. This results in a derived societal 
willingness to pay to avoid the statistical probability of a case of 
AIDS of about $170,000 per year ($373,000 times [1.0000 minus 0.5429]). 
The Car's Catalog of Preference Scores (Ref. 17a) reports average 
preference ratings of 0.375 for cases of AIDS with ranges from 0.0 to 
0.5.
    As discussed earlier, the derived societal willingness to pay to 
avoid a statistical mortality has been estimated to equal approximately 
$5 million.
    Using these estimates, the WTP to avoid the statistical probability 
of an HIV transmission in health care personnel is calculated as the 
sum of:
    [sbull] 20 percent of the percent value (PV) (at 7 percent discount 
rate) of avoiding 40 years of HIV infection.
    [sbull] 32 percent of the sum of the PV of avoiding 5 years of HIV 
infection plus the PV of avoiding 35 years of AIDS infection occurring 
5 years in the future.
    [sbull] 48 percent of the sum of the PV of avoiding 5 years of HIV 
infection plus the PV of avoiding 5 years of AIDS infection occurring 5 
years in the future plus the discounted WTP of avoiding a statistical 
mortality occurring 10 years in the future.
    The PV of avoiding 40 years of health loss valued at $120,000 per 
year is approximately $1.6 million (at 7 percent discount). Twenty 
percent of this figure equals $320,000. The PV of avoiding 5 years of 
health loss to due HIV infection is equal to $492,000. The PV of 
avoiding the health loss expected from 35 years of AIDS infection 
(valued at $170,000 per year) is equivalent to $2.2 million. The 
present value of this amount occurring 5 years in the future (at 7 
percent) is $1.6 million. When added to the PV of avoiding the health 
loss associated with 5 years of HIV infection ($492,000), the total 
estimated present value of the societal willingness to pay to avoid a 
statistical case of this outcome is about $2.1 million. Thirty-two 
percent of this figure equals $660,000. The PV of avoiding the health 
loss expected from 5 years of AIDS infection ($700,000) occurring 5 
years in the future is equivalent to $497,000 (at 7 percent discount 
rate). The PV of avoiding a statistical mortality ($5 million) 10 years 
in the future is $2.54 million (at 7 percent discount). The total 
societal WTP to avoid a case of HIV with mortality as an outcome, 
therefore, is $3.5 million ($493,000 plus $497,000 plus $2.54 million). 
Forty-eight percent of this figure equals approximately $1.7 million. 
Summing the weighted amounts of the three expected outcomes for a case 
of HIV infection ($320,000 plus $660,000 plus $1,700,000) equals an 
estimated societal willingness to pay $2.68 million to avoid a 
statistical transmission of HIV.
    In sum, the estimated societal values of avoiding morbidity and 
mortality due to the transmission of blood-borne pathogens are 
estimated to be equivalent to $1.24 million per transmission of chronic 
HBV and $2.68 million per transmission of HIV. FDA notes that other 
recent cost-effectiveness research (Ref. 18) has reported cost-
effectiveness estimates (excluding pain and suffering) of $2.1 million 
per avoided case of HIV.
    FDA believes the methodology to estimate the value of avoided HBV 
and HIV infection is reasonable and supportable. Nevertheless, 
comparison with reported published preferences show some estimates to 
place higher values on avoidance and some lower than the average 
collected weight. FDA acknowledges these differences and solicits 
comment on other appropriate measures for estimating the societal value 
of avoiding blood-borne infections.
    c. Benefits of morbidity and fatality avoidance. The proposed 
regulation would reduce both HBV and HIV transmissions by reducing the 
prevalence of defective medical gloves used as barrier protection. 
During the first evaluation year, the regulation would result in 0.6 
fewer chronic HBV transmissions to health care personnel. Applying the 
assumed societal WTP of $1.24 million to avoid the statistical 
probability of one chronic HBV infection, the expected benefit of 
avoiding these transmissions is $0.7 million. By the 10th evaluation 
year, 0.8 annual transmissions would be avoided at a value of $1.0 
million. The PV of avoiding almost seven chronic HBV transmissions over 
a 10 year period equals $6.1 million (at a 7 percent discount rate), 
which is equivalent to an average annualized value of $0.9 million for 
the entire 10-year evaluation period.
    Also, in the first evaluation year, FDA expects that the proposed 
regulation would result in the probability of 0.6 fewer transmissions 
of HIV caused by defective gloves. Assuming that society is willing to 
pay $2.68 million to avoid the probability of a single HIV 
transmission, the benefit of avoiding these transmissions equals $1.6 
million. By the 10th evaluation year, FDA expects the proposed 
regulation to result in 0.8 fewer HIV transmissions, which are valued 
at over $2.1 million. The societal PV of avoiding seven transmissions 
of HIV over the 10-year evaluation period is $12.9 million (at 7 
percent discount rate) and is equivalent to an average annualized 
benefit of $1.8 million.
    In sum, FDA estimates that the reduction in blood-borne pathogen 
transmissions due to this proposed rule would produce health benefits 
valued at $2.7 million per year. Much of this benefit (almost 67 
percent) is attributable to reducing the incidence of HIV.
5. Value of Avoiding Unnecessary Blood Screens
    The expected decline in the number of defective medical gloves 
would lead to a smaller number of unnecessary blood screens and thereby 
provide two potential benefits. First, the direct cost of conducting 
screens to determine whether the pathogen was transmitted to health 
care personnel would fall. Second, the psychological anxiety and stress 
that accompanies the possibility that a pathogen was transmitted to an 
individual would decrease.
    a. Cost of conducting blood screens. FDA has collected data from 
the

[[Page 15413]]

American Red Cross (Ref. 5) on the costs of conducting blood screening 
tests designed to ensure the safety of the blood supply. These 
estimates include the costs of collection (including personnel, 
needles, bags, and other supplies) at $47.66 per sample; sample testing 
at $25.16 per sample; and overhead at $3.26 per sample. The estimated 
direct testing cost per blood sample is the sum of these amounts, or 
$76 per test.
    b. Anxiety and stress associated with potential transmission of 
pathogens. The psychological literature has noted that levels of 
anxiety and stress impact participation in public health screening 
programs and thereby affect physiological health (Refs. 19, 20, and 
21). Also, patients who experience high levels of uncertainty due to 
the possibility of contracting serious, threatening diseases experience 
heightened levels of stress and anxiety until the results of the 
testing screens are negative (Ref. 20). According to one measurement 
scale of well-being, reduced mental lucidity, depression, crying, lack 
of concentration, or other signs of adverse psychological sequence may 
detract as much as 8 percent from overall feelings of well-being (Ref. 
16) and have outcomes similar to physiological morbidity. Scaling of 
the relative stress caused by events shows that concerns of personal 
health, by themselves, are likely, on average, to contribute 
approximately one-sixth of the total weighting required to trigger a 
major stressful episode (Refs. 20, 21 and 22). Thus, FDA approximates 
that increased stress and anxiety concerning possible exposure to 
pathogens may reduce overall sense of well-being and result in health 
loss of approximately 1.3 percent (0.013).
    As described earlier, FDA has calculated an assumed WTP of $373,000 
for a statistical QALY. This figure implies that the probability of 
each day of quality adjusted life has a social value of $1,022 
($373,000/365). If blood test results are usually obtained within 24 
hours, the resultant loss of societal well-being for each test subject 
is valued at approximately $13 ($1,022 times 0.013).
    c. Benefit of test avoidance. By combining the avoided direct cost 
of tests and the value of avoided anxiety and stress, FDA estimates 
that the societal benefit of avoiding an unnecessary blood test is $89 
per sample. During the first evaluation year, FDA expects 96,000 fewer 
unnecessary blood screens because of the expected reduction in 
defective medical gloves due to the proposed regulation. The implied 
societal WTP to avoid these unnecessary screens is $8.5 million. During 
the 10th evaluation year, approximately 123,000 fewer unnecessary blood 
screens are expected with a resultant benefit of $10.9 million. The PV 
of each year's reduced cost of testing and anxiety totals $66.5 million 
for the entire period (at a 7 percent discount rate) and an average 
annualized amount of $9.6 million. Of the average annualized amount, 
$8.2 million represents reductions in the direct testing costs and $1.4 
million represents reduced anxiety associated with possible infection 
by a contagious agent.
6. Total Benefits
    FDA estimates that the proposed regulation would reduce the 
availability of defective medical gloves by over 25 percent, resulting 
in over 2.2 billion fewer defective gloves over a 10-year period. 
During this time, FDA expects that reduction in defective gloves would 
result in almost 7 fewer cases of chronic HBV, 7 fewer cases of HIV, 
and 1.1 million fewer unnecessary blood screens. Based on an implied 
societal WTP, the average annualized benefits of the fewer pathogen 
transmissions and unnecessary blood screens would equal $12.3 million.

G. Small Business Impact--Initial Regulatory Flexibility Analysis

    FDA finds that the proposed regulation would not have a significant 
impact on a substantial number of small entities. There are currently 
417 manufacturers of medical gloves, of which 411 are foreign. Because 
medical gloves are almost exclusively manufactured by foreign firms, 
there would not be a significant economic impact on a substantial 
number of domestic small entities. Moreover, FDA does not expect the 
increased manufacturer costs to be directly passed on to end users, 
because the cost increases would affect only a minority of global 
manufacturers and, therefore, competition would require these 
manufacturers to absorb these costs.

H. Conclusion

    FDA has conducted an analysis of the proposed regulation, using 
outside economic consultants. The estimated annualized costs equal $5.2 
million, while the estimated annualized benefits equal $12.3 million. 
FDA certifies that the proposed regulation would not have a significant 
economic impact on a substantial number of small entities because 
medical gloves are imported from foreign manufacturers not subject to 
the Regulatory Flexibility Act. All six domestic manufacturers of 
medical gloves employ more than 1,200 workers. The Small Business 
Administration designates as small any entity with fewer than 500 
employees in this industry.

V. Submission of Comments and Proposed Effective Date

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES), written or electronic comments regarding this document. 
Submit a single copy of electronic comments to http://www.fda.gov/dockets/ecomments
 or two copies of any mailed comments, except that 
individuals may submit one hard copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. Received comments may be seen in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.
    FDA proposes that any final rule that may issue based on this 
proposal become effective 90 days after its date of publication in the 
Federal Register.

VI. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). 
No burden has been estimated for the requirements in Sec.  800.20 
because recordkeeping of tests and samples is a usual and customary 
business practice. Under 5 CFR 1320.3(b)(2), the time, effort, and 
financial resources necessary to comply with a collection of 
information are excluded from the burden estimate if the reporting, 
recordkeeping or disclosure activities needed to comply are usual and 
customary because they would occur in the normal course of activities.

VII. References

    The following references have been placed on display in the Dockets 
Management Branch and may be seen by interested persons between 9 a.m. 
and 4 p.m., Monday through Friday. FDA has verified the Web site 
addresses, but is not responsible for subsequent changes to the Web 
site after this document publishes in the Federal Register.
    1. U.S. Centers for Disease Prevention and Control, ``HIV/AIDS 
Fact Sheet,'' www.cdc.gov, 2002.
    2. U.S. Centers for Disease Prevention and Control, 
``Surveillance of Health Care Workers With HIV/AIDS,'' Oct. 25, 
2001.
    3 U.S. Centers for Disease Prevention and Control, ``Hepatitis 
Fact Sheet,'' www.cdc.gov, 2002.
    4. U.S. Centers for Disease Prevention and Control, ``Updated 
U.S. Public Health Service

[[Page 15414]]

Guidelines for the Management of Occupational Exposures to HBV, HCV, 
and HIV and Recommendations for Postexposure Prophylaxis, Morbidity 
and Mortality Weekly Report, July 17, 2002.
    5. American Red Cross, Washington Post, June 12, 2001.
    6. U.S. International Trade Commission, ``Import Statistics,'' 
www.usitc.gov, 2001.
    7. Eastern Research Group, ``Labeling and Related Testing Costs 
for Medical Glove Manufacturers,'' April 17, 2002.
    8. U.S. Bureau of Labor Statistics, ``Industrial Outlooks,'' 
www.bls.gov, 2002.
    9. Bonel, L., Johns Hopkins University, correspondence with John 
Farnham, July 12, 2002.
    10. Budnick, L., Michigan State University, correspondence with 
John Farnham, July 19, 2002.
    11. Viscusi, K., ``Fatal Tradeoffs: Public and Private 
Responsibilities for Risk,'' Oxford University Press, 1992.
    12. Fisher, A., L. Chestnut, et al., ``The Value of Reducing 
Risks of Death: A Note on New Evidence,'' Journal of Policy, 
Analysis, and Management, 8(1):88-100, 1989.
    13. Mudarri, D., EPA, ``The Costs and Benefits of Smoking 
Restrictions: An Assessment of the Smoke-Free Environment Act of 
1993 (HR 3434),'' 1994.
    14. U.S. National Center for Health Statistics, ``Vital 
Statistics of the United States,'' 2002.
    15. Chen, M., J. Bush, et al., ``Social Indicators for Health 
Planning and Policy Analysis,'' Policy Sciences, 6:71-89, 1975.
    16. Kaplan, R., J. Bush, et al., ``Health Status: Types of 
Validity and the Index of Well-Being,'' Health Services Research, 
winter, 478-507, 1976.
    17. Kaplan, R. and J. Bush, ``Health Related Quality of Life 
Measurement for Evaluation Research and Policy Analysis,'' Health 
Psychology, 1(1):61-80, 1982.
    17a. Harvard Center for Risk Analysis, 2002, ``CUA Database: 
Catalog of Preference Scores,'' Harvard School of Public Health, 
www.hcra.harvard.edu/pdf/preferencescores.pdf, accessed October 26, 
2002.
    18. Marin, M., J. Van Lieu, et al., ``Cost-Effectiveness of a 
Post-Exposure HIV Chemoprophylaxis Program for Blood Exposures in 
Health Care Workers,'' Journal of Occupational and Environmental 
Medicine, 41:9, 754-60, 1999.
    19. Radloff, L., ``The CES-D Scale: A Self-Report Depression 
Scale for Research in the General Population,'' Applied 
Psychological Measurement, 1(3):385-401, 1977.
    20. Shrout, P., ``The Scaling of Stressful Life Events,'' (in) 
Stressful Life Events and their Contents, B. S. Dohrenwend and B. P. 
Dohrenwend (eds), Rutgers University Press, 1984.
    21. Holmes, T. and R. Rahe, ``The Social Readjustment Rating 
Scale,'' Journal of Psychosomatic Research, 11:213-218, 1967.
    22. Davis, M., E. Eshelman, et al., ``The Relaxation and Stress 
Reduction Workbook,'' MJF Books, 1995.

List of Subjects in 21 CFR Part 800

    Administrative practice and procedure, Medical devices, Ophthalmic 
goods and services, Packaging and containers, Reporting and 
recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 800 be amended as follows:

PART 800--GENERAL

    1. The authority citation for 21 CFR part 800 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 334, 351, 352, 355, 360e, 360i, 360k, 
361, 362, 371.
    2. Section 800.20 is amended by revising paragraphs (b), (c), and 
(d) to read as follows:


Sec.  800.20  Patient examination gloves and surgeons' gloves; sample 
plans and test method for leakage defects; adulteration.

* * * * *
    (b)(1) General test method. For the purposes of this part, FDA's 
analysis of gloves for leaks and certain other visual defects will be 
conducted by an initial visual examination and by a water leak method, 
using 1,000 milliliters (ml) of water.
    (i) Units examined. Each medical glove will be analyzed 
independently. When packaged as pairs, each glove is considered 
separately, and both gloves will be analyzed.
    (ii) Identification of defects. For this test, defects are defined 
as tears, embedded foreign objects, or other defects visible upon 
initial examination that may affect the barrier integrity, or leaks 
detected when tested in accordance with paragraph (b)(3) of this 
section. A leak is defined as the appearance of water on the outside of 
the glove. This emergence of water from the glove constitutes a 
watertight barrier failure.
    (iii) Factors for counting defects. One defect in one glove is 
counted as one defect. A defect in both gloves in a pair of gloves is 
counted as two defects. If multiple defects, as defined in paragraph 
(b)(1)(ii) of this section, are found in one glove, they are counted as 
one defect. Visual defects and leaks that are observed in the top 40 
millimeters (mm) of a glove will not be counted as a defect for the 
purposes of this part.
    (2) Leak test materials. The following materials are required for 
testing:
    (i) A 60 mm by 380 mm (clear) plastic cylinder with a hook on one 
end and a mark scored 40 mm from the other end (a cylinder of another 
size may be used if it accommodates both cuff diameter and any water 
above the glove capacity);
    (ii) Elastic strapping with velcro or other fastening material;
    (iii) Automatic water-dispensing apparatus or manual device capable 
of delivering 1,000 ml of water;
    (iv) Stand with horizontal rod for hanging the hook end of the 
plastic tube. The horizontal support rod must be capable of holding the 
weight of the total number of gloves that will be suspended at any one 
time, e.g., five gloves suspended will weigh about 5 kilograms (kg).
    (3) Visual defects and leak test procedures. Examine the sample and 
identify code/lot number, size, and brand as appropriate. Continue the 
visual examination using the following procedures:
    (i) Visual defects examination. Inspect the gloves for visual 
defects by carefully removing the glove from the wrapper, box, or 
package. Visually examine each glove for defects. As noted in paragraph 
(b)(1)(iii) of this section, a visual defect observed in the top 40 mm 
of a glove will not be counted as a defect for the purpose of this 
part. Visually defective gloves do not require further testing, 
however, they must be included in the total number of defective gloves 
counted for the sample.
    (ii) Leak test set-up. (A) During this procedure, ensure that the 
exterior of the glove remains dry. Attach the glove to the plastic fill 
tube by bringing the cuff end to the 40 mm mark and fastening with 
elastic strapping to make a watertight seal.
    (B) Add 1,000 ml of room temperature water (i.e., 20 [deg]C to 30 
[deg]C) into the open end of the fill tube. The water shall pass freely 
into the glove. (With some larger sizes of long-cuffed surgeons' 
gloves, the water level may reach only the base of the thumb. With some 
smaller gloves, the water level may extend several inches up the fill 
tube.)
    (iii) Leak test examination. Immediately after adding the water, 
examine the glove for water leaks. Do not squeeze the glove; use only 
minimum manipulation to spread the fingers to check for leaks. Water 
drops may be blotted to confirm leaking.
    (A) If the glove does not leak immediately, keep the glove/filling 
tube assembly upright and hang the assembly vertically from the 
horizontal rod, using the wire hook on the open end of the fill tube 
(do not support the filled glove while transferring).
    (B) Make a second observation for leaks 2 minutes after addition of 
the water to the glove. Use only minimum manipulation of the fingers to 
check for leaks. Record the number of defective gloves.
    (c) Sampling, inspection, acceptance, and adulteration. In 
performing the test

[[Page 15415]]

for leaks and other visual defects described in paragraph (b) of this 
section, FDA will collect and inspect samples of medical gloves, and 
determine when the gloves are acceptable as set out in paragraphs 
(c)(1) through (c)(3) of this section.
    (1) Sample plans. FDA will collect samples from lots of medical 
gloves in accordance with agency sampling plans. These plans are based 
on sample sizes, levels of sample inspection, and acceptable quality 
levels (AQLs) found in the International Standard Organization's 
standard, ISO 2859, Sampling Procedures For Inspection By Attributes.
    (2) Sample sizes, inspection levels, and minimum AQLs. FDA will use 
single normal sampling for lots of 1,200 gloves or less and multiple 
normal sampling for all larger lots. FDA will use general inspection 
level II in determining the sample size for any lot size. As shown in 
the tables following paragraph (c)(3) of this section, FDA considers a 
1.5 AQL to be the minimum level of quality acceptable for surgeons' 
gloves and a 2.5 AQL to be the minimum level of quality acceptable for 
patient examination gloves.
    (3) Adulteration levels and accept/reject criteria. FDA considers a 
lot of medical gloves to be adulterated when the number of defective 
gloves found in the tested sample meets or exceeds the applicable 
rejection number at the 1.5 AQL for surgeons' gloves or the 2.5 AQL for 
patient examination gloves. These acceptance and rejection numbers are 
identified in the tables following paragraph (c)(3) of this section as 
follows:

         Accept/Reject Criteria at 1.5 AQL for Surgeons' Gloves
------------------------------------------------------------------------
                                                      Number Defective
  Lot                                  Number    -----------------------
 Size     Sample    Sample Size      Examined
                                                      Accept      Reject
------------------------------------------------------------------------
8 to     Single   ..............        8               0         1
 90      sample
------------------------------------------------------------------------
91 to   Single    ..............       32               1         2
 280     sample
------------------------------------------------------------------------
281 to  Single    ..............       50               2         3
 500     sample
------------------------------------------------------------------------
501 to  Single    ..............       80               3         4
 1,200   sample
------------------------------------------------------------------------
1,201   First          32              32               0         4
 to
 3,200
        Second         32              64               1         5
        Third          32              96               2         6
        Fourth         32             128               3         7
        Fifth          32             160               5         8
        Sixth          32             192               7         9
        Seventh        32             224               9         10
------------------------------------------------------------------------
3,201   First          50              50               0         4
 to
 10,00
 0
        Second         50             100               1         6
        Third          50             150               3         8
        Fourth         50             200               5         10
        Fifth          50             250               7         11
        Sixth          50             300              10         12
        Seventh        50             350              13         14
------------------------------------------------------------------------
10,001  First          80              80               0         5
 to
 35,00
 0
        Second         80             160               3         8
        Third          80             240               6         10
        Fourth         80             320               8         13
        Fifth          80             400              11         15
        Sixth          80             480              14         17
        Seventh        80             560              18         19
------------------------------------------------------------------------
35,000  First         125             125               1         7
 and
 above
        Second        125             250               4         10
        Third         125             375               8         13
        Fourth        125             500              12         17
        Fifth         125             625              17         20
        Sixth         125             750              21         23
        Seventh       125             875              25         26
------------------------------------------------------------------------


                        Accept/Reject Criteria at 2.5 AQL for Patient Examination Gloves
----------------------------------------------------------------------------------------------------------------
                                                                                          Number Defective
       Lot Size                   Sample            Sample Size        Number    -------------------------------
                                                                     Examined         Accept           Reject
----------------------------------------------------------------------------------------------------------------
5 to 50                  Single sample            ..............        5               0               1
----------------------------------------------------------------------------------------------------------------
51 to 150               Single sample             ..............       20               1               2
----------------------------------------------------------------------------------------------------------------
151 to 280              Single sample             ..............       32               2               3
----------------------------------------------------------------------------------------------------------------

[[Page 15416]]


281 to 500              Single sample             ..............       50               3               4
----------------------------------------------------------------------------------------------------------------
501 to 1,200            Single sample             ..............       80               5               6
----------------------------------------------------------------------------------------------------------------
1,201 to 3,200          First                          32              32               0               4
                        Second                         32              64               1               6
                        Third                          32              96               3               8
                        Fourth                         32             128               5              10
                        Fifth                          32             160               7              11
                        Sixth                          32             192              10              12
                        Seventh                        32             224              13              14
----------------------------------------------------------------------------------------------------------------
3,201 to 10,000         First                          50              50               0               5
                        Second                         50             100               3               8
                        Third                          50             150               6              10
                        Fourth                         50             200               8              13
                        Fifth                          50             250              11              15
                        Sixth                          50             300              14              17
                        Seventh                        50             350              18              19
----------------------------------------------------------------------------------------------------------------
10,001 to 35,000        First                          80              80               1               7
                        Second                         80             160               4              10
                        Third                          80             240               8              13
                        Fourth                         80             320              12              17
                        Fifth                          80             400              17              20
                        Sixth                          80             480              21              23
                        Seventh                        80             560              25              26
----------------------------------------------------------------------------------------------------------------
35,000 and above        First                         125             125               2               9
                        Second                        125             250               7              14
                        Third                         125             375              13              19
                        Fourth                        125             500              19              25
                        Fifth                         125             625              25              29
                        Sixth                         125             750              31              33
                        Seventh                       125             875              37              38
----------------------------------------------------------------------------------------------------------------

    (d) Compliance. Lots of gloves that are sampled, tested, and 
rejected using procedures in paragraphs (b) and (c) of this section, 
are considered adulterated within the meaning of section 501(c) of the 
act.
    (1) Detention and seizure. Lots of gloves that are adulterated 
under section 501(c) of the act are subject to administrative and 
judicial action, such as detention of imported products and seizure of 
domestic products.
    (2) Reconditioning. FDA may authorize the owner of the product, or 
the owner's representative, to attempt to recondition, i.e., bring into 
compliance with the act, a lot or part of a lot of foreign gloves 
detained at importation, or a lot or part of a lot of seized domestic 
gloves.
    (i) Modified sampling, inspection, and acceptance. If FDA 
authorizes reconditioning of a lot or portion of a lot of adulterated 
gloves, testing to confirm that the reconditioned gloves meet AQLs must 
be performed by an independent testing facility. The following 
tightened sampling plan must be followed, as described in ISO 2859 
``Sampling Procedures for Inspection by Attributes:''
    (A) General inspection level II,
    (B) Single sampling plans for tightened inspection,
    (C) 1.5 AQL for surgeons' gloves, and
    (D) 2.5 AQL for patient examination gloves.
    (ii) Adulteration levels and acceptance criteria for reconditioned 
gloves. (A) FDA considers a lot or part of a lot of adulterated gloves, 
that is reconditioned in accordance with paragraph (d)(2)(i) of this 
section, to be acceptable when the number of defective gloves found in 
the tested sample does not exceed the acceptance number in the 
appropriate tables in paragraph (d)(2)(ii)(B) of this section for 
reconditioned surgeons' gloves or patient examination gloves.
    (B) FDA considers a reconditioned lot of medical gloves to be 
adulterated within the meaning of section 501(c) of the act when the 
number of defective gloves found in the tested sample meets or exceeds 
the applicable rejection number in the tables following paragraph 
(d)(2)(ii)(B) of this section:

                      Accept/Reject Criteria at 1.5 AQL for Reconditioned Surgeons' Gloves
----------------------------------------------------------------------------------------------------------------
                                                                                          Number Defective
       Lot Size                   Sample            Sample Size        Number    -------------------------------
                                                                     Examined         Accept           Reject
----------------------------------------------------------------------------------------------------------------
13 to 90                Single sample             ..............       13               0               1
----------------------------------------------------------------------------------------------------------------

[[Page 15417]]


91 to 500               Single sample             ..............       50               1               2
----------------------------------------------------------------------------------------------------------------
501 to 1,200             Single sample            ..............       80               2               3
----------------------------------------------------------------------------------------------------------------
1,201 to 3,200          Single sample             ..............      125               3               4
----------------------------------------------------------------------------------------------------------------
3,201 to 10,000         Single sample             ..............      200               5               6
----------------------------------------------------------------------------------------------------------------
10,001 to 35,000        Single sample             ..............      315               8               9
----------------------------------------------------------------------------------------------------------------
35,000 and above        Single sample             ..............      500              12              13
----------------------------------------------------------------------------------------------------------------


                 Accept/Reject Criteria at 2.5 AQL for Reconditioned Patient Examination Gloves
----------------------------------------------------------------------------------------------------------------
                                                                                          Number Defective
       Lot Size                   Sample            Sample Size        Number    -------------------------------
                                                                     Examined         Accept           Reject
----------------------------------------------------------------------------------------------------------------
8 to 50                 Single sample             ..............        8               0               1
----------------------------------------------------------------------------------------------------------------
51 to 280               Single sample             ..............       32               1               2
----------------------------------------------------------------------------------------------------------------
281 to 500               Single sample            ..............       50               2               3
----------------------------------------------------------------------------------------------------------------
501 to 1,200            Single sample             ..............       80               3               4
----------------------------------------------------------------------------------------------------------------
1,201 to 3,200          Single sample             ..............      125               5               6
----------------------------------------------------------------------------------------------------------------
3,201 to 10,000         Single sample             ..............      200               8               9
----------------------------------------------------------------------------------------------------------------
 10,001 to 35,000       Single sample             ..............      315              12              13
----------------------------------------------------------------------------------------------------------------
35,000 and above        Single sample             ..............      500              18              19
----------------------------------------------------------------------------------------------------------------


    Dated: March 21, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-7601 Filed 3-28-03; 8:45 am]

BILLING CODE 4160-01-S