For questions regarding this document contact John Stigi at 240-276-3150 ext. 124 or via email at john.stigi@fda.hhs.gov.
|
U.S. Department of Health and Human Services Office of Communication, Education and Radiation Programs |
Written comments and suggestions may be submitted at any time for Agency consideration to:
Director, Division of Small Manufacturers, International and Consumer Assistance,
Center for Devices and Radiological Health (HFZ-220),
Food and Drug Administration,
1350 Piccard Dr . ,
Rockville , MD 20850 .
Alternatively, electronic comments may be submitted to dsmica@fda.hhs.gov.
When submitting comments, please refer to the exact title of this guidance document. Comments may not be acted upon by the Agency until the document is next revised or updated.
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. |
This manual provides FDA’s recommendations for Premarket Notification (510(k)) submissions for medical gloves. It also provides our recommendations on how to comply with the Quality System regulation (21 CFR part 820). Previous revisions of this manual were entitled “Guidance for Medical Gloves: A Workshop Manual.” This edition, the “Medical Glove Guidance Manual” (manual), supersedes all earlier revisions and explains FDA’s current thinking on the requirements and recommendations for medical gloves that are marketed in the United States (U.S.).
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
The issues identified in this guidance document represent those that we believe should be addressed before your device can be marketed. In developing the guidance, we carefully considered the relevant statutory criteria for Agency decision-making. We also considered the burden that may be incurred in your attempt to follow the guidance and address the issues we have identified. We believe that we have considered the least burdensome approach to resolving the issues presented in the guidance document. If, however, you believe that there is a less burdensome way to address the issues, you should follow the procedures outlined in the “A Suggested Approach to Resolving Least Burdensome Issues” document. It is available on our Center web page at http://www.fda.gov/cdrh/modact/leastburdensome.html.
Introduction
Medical gloves, including surgeon’s and patient examination gloves, are used to prevent transmission of a wide variety of diseases to both patients and health care personnel. This manual contains information on the regulatory requirements for patient examination gloves and surgeon's gloves, as well as FDA’s recommendations for meeting those requirements.
General Controls
Medical gloves are class I reserved devices and are subject to general controls (section 513(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act (Act); 21 U.S.C. 360c(a)(1)(A)), which include:
Establishment Registration
Device Listing
Premarket Notification 510(k)
Labeling
Quality System
Medical Device Reporting (MDR) – reporting of adverse events associated with a medical device.
In addition, foreign firms must name a U.S. Agent (21 CFR 807.40). You can find additional information on medical device regulatory requirements on FDA’s Device Advice website at http://www.fda.gov/cdrh/devadvice/.
You may obtain assistance on any regulatory issue from the Division of Small Manufacturers, International, and Consumer Assistance (DSMICA). Contact information for DSMICA is the following:
Division of Small Manufacturers, International, and Consumer Assistance
Phone: 240-276-3150 or 800-638-2041
Email: dsmica@cdrh.fda.gov
Fax: 240-276-3151
21 CFR 880.6250 Patient examination glove.
Table 1.1 Patient Examination Glove, 21 CFR 880.6250
Common Name |
Product Code |
Latex |
LYY |
Vinyl (PVC) |
LYZ |
Polymer – other than Vinyl |
LZA |
Finger Cot |
LZB |
Specialty: Chemotherapy, etc. |
LZC |
The subcategories of gloves described in Table 1.1 are all special forms of the category “patient examination glove.” These gloves should meet the requirements for a patient examination glove, as well as additional 510(k) and labeling recommendations described in the following paragraphs:
Specialty/Chemotherapy Labeling Claim. Medical gloves cleared for marketing with chemotherapy labeling claims (often referred to as chemotherapy gloves) are specialty patient examination gloves. These gloves should meet the current FDA-recognized consensus standard for patient examination gloves or an equivalent test method.
We recommend that you follow the 510(k) format for examination gloves outlined in Chapter 6 for chemotherapy glove 510(k) submissions. The 510(k) submission should also include permeation and penetration data based on actual testing with chemotherapeutic drugs.
For additional information, refer to Chemotherapy Labeling Claim in Chapter 4.
Dental Patient Examination Gloves . Gloves worn during dental cleaning, filling, and other dental procedures are patient examination gloves. These gloves should meet the requirements for patient examination gloves. You may use the term "dental" in the labeling of gloves intended for dentistry. The term “dental” should always be used with, and does not replace, the term “patient examination glove.”
21 CFR 878.4460 Surgeon’s glove.
Surgeon’s gloves are subject to the design control requirements of the Quality System regulation (21 CFR 820.30(a)(2)(ii)).
Surgeon’s gloves should be sterile when offered for sale to end users, such as hospitals, clinics, and surgeons. FDA has not cleared any 510(k)’s for non-sterile surgeon’s gloves. A 510(k) submission for surgeon’s gloves should include information about the sterilization method and cycle. The provisions in 21 CFR 801.150(e) regulate the shipment of medical gloves to and from a contract sterilizer. See Chapter 8 for additional information.
Table 1.2 Surgeon's Glove,21 CFR 878.4460
Common Name |
Product Code |
Surgeon’s Glove (including Dental Surgeon’s gloves) |
KGO |
The subcategories of gloves described in Table 1.2 are all special forms of the category “surgeon’s glove.” These gloves should meet the requirements for a surgeon’s glove as well as additional 510(k) and labeling recommendations described in the following paragraphs:
Dental Surgeon’s Glove . You may use the term "dental" in the labeling of gloves intended for dental surgery. Gloves for dental surgery may be thicker than standard surgeon’s gloves. The labeling may include the measured thickness of the gloves, but you should not use ambiguous terms such as "extra thick."
Microsurgery Glove . Microsurgery gloves are carefully processed to have decreased thickness in certain areas, particularly at the fingertips. To date FDA has not cleared any 510(k) submissions for microsurgery gloves that are thinner than the specifications in the FDA-recognized consensus standard for surgeon’s gloves. As with all surgeon’s gloves, testing should demonstrate safety and effectiveness for its indications for use.
Orthopedic Surgeon’s Glove . Orthopedic surgical gloves may be larger, thicker, and more resistant to tear than other surgical gloves. You may state the measured thickness and other parameters of orthopedic gloves in the labeling. You should not use ambiguous terms, such as "extra thick," or "super strong."
Autopsy Surgeon’s Glove . Autopsy gloves are intended for use during autopsy procedures and may be similar to orthopedic surgeon’s gloves. These gloves are subject to the same regulatory requirements as surgeon’s gloves.
Specialty/Chemotherapy Labeling Claim. We recommend that you follow the 510(k) format for surgeon’s gloves outlined in Chapter 7 for chemotherapy glove 510(k) submissions. The 510(k) should also include permeation and penetration data based on actual testing with chemotherapeutic drugs. We recommend that surgeon’s gloves with chemotherapy labeling claims follow the current FDA-recognized consensus standards for surgeon’s gloves or an equivalent test method.
For additional information, refer to Chemotherapy Label Claim (under Attribute Labeling) in Chapter 4.
Radiation Attenuating Surgeon’s Glove. Radiation attenuating surgeon’s gloves are used during surgical procedures involving radiation exposure to the hands. The gloves offer some degree of protection to the hand from radiation exposure as well as protection from transmission of infectious agents. The use of these gloves includes surgical procedures that require the use of fluoroscopy or radiography. In addition to meeting the requirements for a surgeon’s glove, manufacturers should have technical data to show that their attenuation claims meet the energy range of x-rays normally used in medical procedures.
A medical device kit may include medical gloves. Kit manufacturers and assemblers should assure that gloves in their kits are cleared for marketing and that the gloves can meet the appropriate FDA and ASTM standard (such as ASTM D3577, ASTM D3578, ASTM D5250, ASTM D6319) or an equivalent test method after the kit is sterilized.
We recommend that you enclose natural rubber latex gloves in their own packaging within the kit to avoid possible protein contamination of other devices. You must label the kit appropriately for any device or packaging containing natural rubber (21 CFR 801.437).
You may refer to the following documents for additional guidance:
Convenience Kits Interim Regulatory Guidance
http://www.fda.gov/cdrh/ode/convkit.htmlSterilized Convenience Kits for Clinical and Surgical Use http://www.fda.gov/cdrh/comp/guidance/1390.html
Table 1.3 Classification codes for accessories
Common Name |
Product Code |
Regulation Number |
Glove Liners/Undergloves |
KGO |
21 CFR 878.4460 |
Surgeon’s Gloving Cream |
KGQ |
21 CFR 878.4470 |
Glove Liners/Undergloves . Glove liners or undergloves are worn with patient examination or surgeon’s gloves. They may be made of materials such as cotton to prevent the medical glove from contacting the user’s hand, or they may be made of materials that are resistant to cutting or puncture. The glove liners provide added protection by reducing the risk of a cut or puncture wound during surgical or examination procedures and by absorbing perspiration. Unless separately classified, accessories to medical gloves have the same classification (regulation number) as the gloves with which they are used.
Medical device regulations apply to glove liners and undergloves. Because glove liners and undergloves contact the skin, you should submit biocompatibility data with a 510(k) submission to show that they are safe for their intended use (See Chapter 3, Biocompatibility). If your labeling states that your glove liners provide a protective barrier, then the glove liners should meet the quality limit for barrier defects (pinholes) in the FDA-recognized consensus standard (or an equivalent standard) for the glove to which the liner is an accessory.
Surgeon’s Gloving Cream . Surgeon’s gloving cream lubricates the user’s hand before putting on a surgeon’s glove. This cream may also be used with examination gloves. FDA classified gloving cream as a class I device under 21 CFR 878.4470. Gloving cream is exempt from 510(k) submission requirements unless the intended use of the cream is different from that described in 21 CFR 878.4470, i.e., "lubricating the user's hand…." Gloving creams should not degrade the glove material in latex gloves or other gloves, i.e., the creams should not be oil-based. If a manufacturer modifies the ingredients of an existing gloving cream or introduces a new gloving cream into commercial distribution, the manufacturer should ensure that the cream performs as claimed. The manufacturer also should maintain biocompatibility data on file to show that the new or modified cream is safe and effective for the intended use.
Radiographic Protection Glove . FDA classified radiographic protection gloves as a "personnel protective shield" under 21 CFR 892.6500 (product code IWP). This is a class I device and is exempt from Premarket Notification (510(k)). The gloves are intended to protect the operator, patient, or other person from unnecessary exposure to radiation during radiological procedures by providing an attenuating barrier to radiation. We recommend that you maintain technical data to show that their attenuation claims meet the energy range of x-rays normally used in medical procedures.
If radiographic protection gloves are also intended for use as medical gloves, FDA classifies them as either patient examination gloves or surgeon’s gloves and they are subject to 510(k) clearance.
Leak Detectors . Leak detectors are chemical, electromechanical, or electronic systems designed for the glove user to monitor glove barrier integrity immediately before and during glove use. FDA classifies these devices as accessories to medical gloves. Leak detectors used as medical devices should have 510(k) clearance before marketing.
Leak testers and other equipment used during the production of gloves are production equipment; they are not medical devices. The Quality System regulation in 21 CFR 820.70 and 820.72 covers the selection, use, control, and maintenance of production equipment.
Embalming Gloves . The Occupational Safety and Health Administration (OSHA) regulates embalming gloves.
Food Service Gloves . FDA considers food service gloves to be a food contact surface which may result in the addition of indirect food additives to the food handled. FDA’s Center for Food Safety and Applied Nutrition (CFSAN) regulates food service gloves.
Gloves used for food handling or preparation are not medical devices; therefore, they are not subject to the 510(k) premarket review process and thus are not cleared for marketing by FDA’s Center for Devices and Radiological Health (CDRH). Labeling of food service gloves should not, in any way, represent or suggest that they may be used for medical purposes. This may include the brand name and company name.
For further information regarding additives and food use of gloves, contact CFSAN at 301-436-2600 (phone) or oco3@cfsan.fda.gov (email).
The National Sanitation Foundation (NSF) has developed a protocol for food service gloves identified as “P155: Disposable Food Contact Gloves.” This document is available at http://www.nsf.org/.
Cleaning Gloves. FDA does not regulate gloves that are used for routine janitorial functions in medical facilities. However, gloves that are used for cleaning patients, or cleaning or handling surfaces or items contaminated with patient waste or fluids are medical gloves and should meet the requirements for patient examination gloves.
Utility, industrial, or general purpose gloves are used for tasks that do not involve contact with patients or body fluids. Therefore, FDA does not regulate them as medical devices. It is illegal for manufacturers to relabel these gloves for medical use or to imply in their labeling that the gloves are suitable for medical use. Labeling of utility, industrial, and general purpose gloves should not, in any way, represent or suggest that they may be used for medical purposes. This may include the brand name and company name.Donning lubricants such as cornstarch and silicone may make it easier to put on medical gloves. Powdered lubricants are also called donning powders or dusting powders. Powder from medical gloves directly contacts wounds, body cavities, and skin and can contaminate both the patient’s and the user’s environment. FDA believes it is important to minimize the amount of powder on finished gloves. We recommend that you establish a specification for the amount of powder on a glove and a procedure to verify that powder levels on finished gloves meet that specification.
A small amount of silicone or other lubricant is also used on some powder-free gloves to aid in donning. If used, the lubricants should be on the finished gloves when you conduct biocompatibility tests. You should identify the complete chemical characterization/chemical formulation of the lubricant in the 510(k) submission.
Examination Gloves. Cornstarch that meets the specification for absorbable donning or dusting powder in the United States Pharmacopeia (U.S.P.) is a commonly used lubricant for examination gloves. Any powder used for lubricating examination gloves should meet the U.S.P. monograph for absorbable dusting powder or be equivalent in terms of safety and effectiveness. The 510(k) submission should state the type, specifications, and source of powder or other donning lubricant used on the gloves. You should not use talc, cotton flock, and other non-absorbable materials as a lubricating, dusting, or donning powder. Recognized consensus standards specify that the inside and outside surface of medical gloves be free of talc. Lycopodium (club moss spores) and ground pine pollen are toxic. You should not use them as powder on or in medical gloves.
Surgeon’s Gloves. Absorbable dusting powder for lubricating a surgeon’s glove is a transitional device (a device formerly regulated as a new drug before l976). FDA classifies it as a class III medical device under 21 CFR 878.4480 (product code KGP). Absorbable dusting powder for lubricating a surgeon’s glove requires an approved Premarket Approval Application (PMA) or, if marketed prior to May 28, l976, a New Drug Application (NDA). You may use only absorbable dusting powders manufactured under an approved PMA or NDA on powdered surgeon’s gloves.
A current list of approved NDAs or PMAs for Surgical Dusting Powder is available through the PMA database on the FDA website. Place KGP in the Product Code box and click on Search.
PMA database: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm
Guidance on the content and format for a PMA for Absorbable Powder for Lubricating a Surgeon’s Glove is available at:
Premarket Approval Applications (PMA) for Absorbable Powder for Lubricating a Surgeon’s Glove
http://www.fda.gov/cdrh/ode/guidance/1230.html
Device Advice PMA
In order to have uniform distribution of the latex mix on the mold, commonly called a “former,” the mold is first dipped in a coagulant solution usually containing a calcium salt in water. In addition, the coagulant solution sometimes contains a lubrication agent to facilitate stripping (removing) the gloves from the molds at the end of the production line. A small amount of the coagulant and release agent remains on the "inside" surface of the glove. In some processes, washing removes most of the mold release agent from the surface of the glove. If these manufacturing material residues can adversely affect the safety or effectiveness of the gloves, you must establish and maintain procedures for the use and removal of the manufacturing material to ensure that it is removed or limited to an amount that does not adversely affect the gloves's quality (21 CFR 820.70(h).
We recommend that you conduct biocompatibility testing as described in the guidance entitled, “ Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,” available at http://www.fda.gov/cdrh/g951.html on finished gloves. You should select biocompatibility tests appropriate for both surface and external communicating devices with limited duration (24 hours) of contact. Because medical gloves are in direct contact with skin, a primary skin irritation study and a dermal sensitization study are appropriate.
You should perform biocompatibility tests on finished gloves. The gloves used for biocompatibility studies should contain the same colorants, fragrances, flavors, powders, lubricants, and processing chemicals. You should test gloves that have been processed, packaged, and if appropriate, sterilized by the same methods as the gloves you will distribute. You should consider the need to repeat biocompatibility studies if you make subsequent changes in glove composition, manufacturing materials, or processing.
The 510(k) submission should include biocompatibility test results and other information and data described in this manual as an attached report for each major study or test program. You should identify all reports or attachments with the manufacturer’s name, number the pages, and list the reports or attachments in the table of contents. For sterile devices, test data should include the results of tests performed using the finished sterilized devices.
You and the contract laboratory, if used, should check the:
We recommend that you present the summary of test results in a table formatin each report whenever possible. Each study or test attachment report should contain sufficient and well-organized information in reasonable detail so that the FDA reviewer can determine:
We recommend that you submit reasonable and sufficient details of all test procedures and results to FDA. For biocompatibility studies, you should use a standard scoring system for each test method, if a standard scoring system exists. We recommend each test report include the following:
You should keep the original records of the study on file. For surgeon’s gloves, the records should be maintained as part of your design verification records in the design history file. You should also maintain the original records when a study, such as a biocompatibility study, is conducted by a contract laboratory to establish a device specification and/or to obtain data for a submission to FDA. The original document should include the name and address of the laboratory and device manufacturer, the device identity, and dates of testing. You should not submit the original records to FDA. During factory inspections, FDA investigators may ask to see these original records.
The following is a general discussion of how to conduct the skin irritation and dermal sensitization studies. Because methods may vary from laboratory to laboratory, the test data you submit to FDA should contain a brief description of the test protocol, scoring criteria used, and the method used for rating skin responses.
Primary Skin Irritation Test (Animal Study)
Performing skin irritation testing demonstrates the irritation potential of the gloves, i.e., for initiating or aggravating damage through its contact with the skin. We recommend that you perform the primary skin irritation testing according to the regulations of the Consumer Product Safety Commission ( 16 CFR 1500.41). We recommend that you identify the inside and outside of the gloves so that both sides are tested, i.e., approximately half of the test articles expose opposite sides of the glove to the subject .
Dermal Sensitization Study (Animal Study)
The purpose of performing dermal sensitization is to demonstrate the potential of the device for eliciting a delayed hypersensitivity (Type IV) immunologic response through its contact with the skin. This reaction is due primarily to substances which could leach out of a material. Guinea pigs are used because they have been shown to be the best animal model for human allergic contact dermatitis. We recommend the method described in ASTM
standard F720-86, Standard Practice for Testing Guinea Pigs for Contact Allergens, Guinea Pig Maximization Test, for the study. Laboratories may also use the method of Buehler, as reported in Archives of Dermatology (1965). Dermal sensitization studies use two tests or phases: the induction phase and challenge phase. You should identify the inside and outside of the gloves so that both sides are tested, i.e., approximately half of the test articles expose opposite sides of the glove to the subject.
Testing for Skin Sensitization to Chemicals
Your labeling may include special claims regarding reduced potential chemical sensitization in a 510(k), such as:
You should support these claims by data from human testing. Additional guidance on testing for skin sensitization to chemicals in latex products is available in the following guidance document:
Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization to Chemicals in Natural Rubber Products
If you have already conducted a Modified Draize Test (MDT) on a minimum of 200 human subjects to support a reduced sensitization claim, you may use the MDT data instead of the primary skin irritation test (animal) and dermal sensitization study (animal) typically used to support the general biocompatibility of medical gloves.
You should show that any substance added to the gloves, including color, flavor, and/or scent additives, does not adversely affect the safety or effectiveness of the gloves. Therefore, if a device contains a color or other chemical additive and the device is intended to be in contact with the skin or other parts of the body, you should submit biocompatibility data to demonstrate the safety of the additives, unless you can establish that the additives would not leach and contact the body.
FDA considers the addition of color, flavor, or any chemical to a medical glove to be a significant change that should have a new 510(k) submission (21 CFR 807.81(a)(3)).You should provide full characterization and chemical identity of the color, flavor, or scent additives. You may submit a 510(k) submission for a modification to an existing glove as a “Special 510(k).” Additional information about Special 510(k) submissions is available at http://www.fda.gov/cdrh/devadvice/3144.html.
You can find color additive and flavor additive regulations in 21 CFR parts 70 to 82 and 21 CFR part 172, Subpart F, respectively. Note that color and flavor additives contained in these regulations are specific to foods, drugs, and cosmetics. The color additive regulations should not be confused with the general 510(k) requirements, which are independent of the color additive listing and certification mentioned above. You should show that any color or flavor substance added to a device does not adversely affect the safety or effectiveness of the device. Gloves that contain FDA-approved color or flavor additives for foods, drugs, or cosmetics should undergo biocompatibility testing to demonstrate the safety of the additives in the device. We may accept other color or flavor additives not contained in these regulations with appropriate biocompatibility testing.
Medical device labeling requirements do not require the glove box or carton to have an "ingredient statement" listing the flavor agent, colorant, or other additives used in the manufacture of the glove. However, manufacturers may do so voluntarily.
See Chapter 4 for labeling considerations for medical gloves with color and flavor additives.
The websites below may be helpful in finding a testing laboratory. FDA does not certify testing laboratories. As with any supplier of services, you should verify the adequacy of the services offered (21 CFR 820.50(a)).
The American Association for Laboratory Accreditation
http://www.a2la2.net/American Council for Independent Laboratories
http://www.acil.org/ASTM International
http://www.astm.org/LABS/Canon Communications
http://www.devicelink.com/consult/BiocompatibilityToxicology.html
http://www.devicelink.com/company98/category/Testing_Equipment_and_Services/index.htmlFindtesting.com http://www.findtesting.com/directory/category.asp?category=biological&page=7
Thomas Register
http://www.thomasnet.comSearch categories include:
Testing Services: Safety
Testing Services: Latex
Testing Services: Medical Equipment
Testing Services: Medical Device
International Testing & Compliance Services
Product Safety Testing Services
DEVICES THAT CONTAIN NATURAL RUBBER
You can find general labeling requirements for all medical devices in 21 CFR part 801. Specific labeling requirements for devices made from natural rubber latex are provided in 21 CFR 801.437.
Name and Place of Business
Country of Origin
The label must contain the country of origin if other than the U.S. (19 CFR 134.11). The U.S. Customs and Border Protection enforces this regulation.
Statement of Identity (21 CFR 801.61)
Language
All labeling must be in English with the exception of those products distributed solely within Puerto Rico or a U.S. Territory where the predominant language is not English (21 CFR 801.15(c)(1)). If any representation on the device label or labeling appears in a foreign language, then all required labeling must also appear in that foreign language (21 CFR 801.15(c)(3)).
Net Quantity of Contents Statement
The label must contain a statement of net quantity of contents in terms of weight, measure, numerical count, or statements of both numerical count and weight, measure, or size (21 CFR 801.62(a)). Whichever statement of net quantity of contents you use, you should state it clearly and understandably on the label, e.g., “100 gloves, packaged by weight.”
The net quantity declaration must appear as a separate item in the lower 30 percent of each principal display panel. You must separate it, by at least a space equal to the height of the lettering used in the declaration, from other information appearing above and below. Also, you must separate the declaration by at least twice the width of the letter “N” from labeling to the left or right. (21 CFR 801.62(e)).
Adequate Directions for Use
You should label disposable medical gloves as "single use only." The label for surgeon’sgloves should contain any necessary directions for use.
Caution Statement. If your medical gloves contain natural rubber latex, you must put the following statement in bold print on the device labeling:
“Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.”
This statement must appear on all device labels, and other labeling, as well as on the principal display panel of the device packaging, the outside package, container, or wrapper, and the immediate device package, container, or wrapper (21 CFR 801.437(d)).
Expiration date labeling for medical gloves is voluntary. However, if you make an expiration date labeling claim, the gloves should meet the performance characteristics and specifications presented in the Premarket Notification (510(k)) over the entire claimed shelf life. Manufacturers with cleared 510(k) submissions for surgeon’s or patient examination gloves do not have to submit new 510(k) submissions to add an expiration date to the labeling.
You should perform real-time stability studies in order to determine an expiration date. The stability studies should include tests to verify that medical gloves maintain their barrier properties, physical properties, packaging integrity, sterility, and any specific attributes claimed in the labeling over the entire shelf life of the glove. We recommend the following tests:
Manufacturers/sponsors may use test protocols from the applicable voluntary consensus standards or may develop their own protocols for stability testing. If you develop original protocols, you should describe the protocols in detail (test methodology, acceptance criteria, time intervals for testing). You should give a rationale for any variation from the applicable consensus standard. Manufacturers should maintain the originals of all protocols, test reports, and identification of persons/labs performing the test at their manufacturing establishment so that the information is available for review during an FDA inspection.
Provisional Expiration Date
FDA will accept a provisional expiration date of up to 3 years from the date of manufacture based on accelerated aging studies, provided the manufacturer immediately initiates real-time stability testing to obtain data to support the proposed expiration date. You should perform accelerated aging studies at a minimum of two elevated temperatures between 40 and 80 degrees C°. If the product does not meet the required criteria after accelerated aging, you should label the product with a shelf life determined by real-time testing. FDA believes that expiration dates based on real time data should not exceed 5 years from the date of manufacture. If the real-time data do not support the expiration date based on accelerated aging, you should change the expiration date to reflect actual shelf life.
Test Reports
We recommend that you generate test reports to document both the real-time and accelerated aging of the gloves. Test report documentation should be consistent with the appropriate standards. In addition, we recommend that each test report should include the following information:
Labeling
When you establish the shelf life of the gloves using real time stability testing, or when you establish a provisional shelf life using accelerated aging, the expiration date labeling on medical gloves should conform with the following:
ASTM International developed the following standards for expiration dating of medical gloves:
You can obtain more information on these standards directly from ASTM at http://www.astm.org.
If surgeon’s gloves are powdered, they must be powdered with an absorbable dusting powder that has received FDA approval under either an NDA or a PMA (21 CFR 878.4480). The labeling should inform users with a statement such as, “Powdered with absorbable dusting powder.” Absorbable powder for lubricating a surgeon’s glove is a Class III medical device under 21 CFR 878.4480. For more information about glove lubricants, see Chapter 2 of this manual.
If patient examination gloves are powdered, the powder should meet the United States Pharmacopoeia (U.S.P.) monograph for absorbable dusting powder or demonstrate equivalence in terms of safety and effectiveness. U.S.P powder is commonly used on examination gloves so the corresponding labeling statement should read, “Powdered with absorbable dusting powder, U.S.P.”
In addition to basic labeling described above, manufacturers may have labeling claims for the attributes of their gloves. Some attributes are color, flavor, scent, and thickness. You should submit data to support all claims in your 510(k). You should not use ambiguous labeling claims such as “extra thick” or “super-sensitive” because they are misleading. You should use acceptable factual and definitive statements, such as the actual glove thickness as determined by measurement.
Section 502 of the Act prohibits labeling that is false or misleading in any way (21 U.S.C. 352). Any labeling claim should describe the device truthfully and accurately. See Chapter 9, Compliance Activities, for more information on labeling.
“Powder-Free”
Gloves with trace amounts of residual former-release powder (2 mg or less per glove) and no intentionally added donning powders are commonly referred to as “powder free.” Most manufacturers dip the glove mold, known as a “former,” into a solution of calcium carbonate and calcium nitrate. After controlled drying, manufacturers dip the coated former into the latex solution and create a glove on the former. The calcium carbonate helps release the glove from the former. An extremely small amount of calcium carbonate remains on the glove. Most of it is removed by leaching and washing.
FDA has recognized standard method ASTM D6124, Standard Test Method for Residual Powder on Medical Gloves, for collecting and measuring the manufacturing debris, residual former-release powder, and other elements on a powder-free glove or the powder levels on powdered medical gloves.
To establish a “powder-free” claim, FDA recommends that you have no more than 2 mg of residual or trace powder and debris per glove, as determined by the ASTM D6124 test method (Standard Test Method for Residual Powder on Medical Gloves) or an equivalent method.
Protein Label Claims
Latex proteins can cause Type I sensitivity in some individuals who have been exposed to latex-containing devices. Repeated exposure to latex proteins may increase the probability that an individual will become sensitized. Since May 1991, the FDA has recommended that manufacturers of latex devices reduce the water-extractable protein on their natural rubber latex devices. FDA considers water soluble latex proteins to be concomitant constituents, which are manufacturing materials under the Quality System regulation, 21 CFR 820.3(p). FDA requires the reduction of these types of materials according to 21 CFR 820.70(h).
Manufacturers who can reliably reduce the levels of latex proteins in their gloves to a known level may make a labeling claim, if they submit supporting data in their 510(k) submission. At present, FDA does not allow a protein labeling statement or claim below the current 50µg/dm 2 sensitivity limit of the ASTM Lowry test method (D5712). Work is being done to determine the sensitivity and detection limits of the ELISA test method (ASTM D6499). At the time of this writing, these limits are unknown.
FDA suggests that you measure the natural rubber latex protein on recently manufactured finished gloves that have undergone accelerated aging according to the ASTM standard D3578 (Standard Specification for Rubber Examination Gloves) or D3577 (Standard Specification for Rubber Surgical Gloves) or real time aging. Water soluble proteins may migrate to the glove surface during shipping. Aging should approximate this time period.
If you label your gloves as containing 50µg/dm 2 or less per glove of extractable protein, the labeling should also state:
“Caution: Safe use of these gloves by latex sensitized individuals has not been established.”
You must ensure that any labeling changes to dispenser boxes and any changes to manufacturing processes meet the requirements of the Quality Systems regulation in 21 CFR 820.30 (for surgeon’s gloves), 820.40 and 820.70. See Chapter 8, Quality System, for further guidance.
Chemical Sensitization
Certain chemicals routinely used in the manufacture of medical gloves, such as natural rubber latex and other materials, can cause skin sensitization and irritation. If you sufficiently reduce or eliminate the presence of these chemicals, you may make appropriate labeling claims regarding the reduced potential of chemical sensitization or reduced reaction-inducing potential of your gloves in allergic individuals if cleared in a 510(k) submission. You can find guidance about reduced sensitization claims for latex gloves in the guidance document “Premarket Notification (510(k)) Submissions for Testing for Skin Sensitization to Chemicals in Natural Rubber Products” at http://www.fda.gov/cdrh/ode/944.html. Refer to Chapter 3, Biocompatibility, for additional information on biocompatibility.
Color and Flavor Additives
Medical device labeling does not require an “ingredients statement” listing the flavor agents or colorants used in the manufacture of the gloves on the glove box or carton. However, manufacturers may do so voluntarily.
FDA considers the addition of colorants, other than traditional whiteners, such as titanium dioxide or the addition of a flavoring agent to a medical glove, to be a significant change which should have 510(k) clearance (21 CFR 807.81(a)(3)). The new finished glove should undergo full biocompatibility testing.
Chemotherapy Label Claim
Medical gloves with a chemotherapy claim should meet an appropriate FDA-recognized consensus standard for medical gloves or an equivalent test method. Physical features such as increased thickness and length make these gloves more suitable for the safe handling of chemotherapy agents (usually minimal thickness of 0.10 mm, minimal length of 270 mm). Gloves for use with chemotherapy agents should also undergo the standard biocompatibility testing for medical gloves.
To market the glove for use in the handling and/or preparation of chemotherapeutic drugs, you should label the glove as a “Patient Examination Glove” or “Surgeon’s Glove” and “Tested for use with [name of chemotherapeutic drug(s)].”
We recommend that you include the following labeling information (to enable the user to make an appropriate product selection):
Pyrogen/Endotoxin Labeling Claim
FDA may consider a non-pyrogenic claim on a case-by-case basis for surgeon’s gloves. The 510(k) submission should contain data to support the claim. In addition, the Quality System regulation includes requirements for, but not limited to, design controls, process validation, and process controls (21 CFR part 820). If you label your glove as non-pyrogenic, you should design the glove and validate the manufacturing process from the onset of manufacture to the finished packaged device. You should continuously monitor the bioburden throughout the entire process to assure the bioburden is within the validated specifications. The bioburden monitoring should include the slurry tank for the glove powder used to lubricate the gloves, as well as any bacterial over-growth that may occur subsequent to powdering and prior to sterilization. You should establish manufacturing timeframes to minimize growth at every stage of the process.
Hypoallergenicity
For medical gloves distributed after September 30, 1998, 21 CFR 801.437(h) states “Devices that contain natural rubber that contacts humans...shall not contain the term ‘hypoallergenic’ on their labeling.” This includes gloves that have received prior 510(k) marketing clearance with a claim of hypoallergenicity. Hypoallergenic incorrectly implies that latex sensitive persons may use a product labeled as “hypoallergenic” safely.
FDA strongly discourages the use of the term “hypoallergenic” because the term cannot be scientifically defined or quantified. Because there is virtually no way to rule out allergies to any substance, FDA strongly discourages using the term “hypoallergenic” regarding any medical device, whether the device contains natural rubber latex or not.
FDA does not require a new 510(k) submission for labeling changes made to comply with 21 CFR 801.437, provided that you do not make any other changes requiring a new 510(k) submission. However, you should keep appropriate records documenting the labeling changes.
For voluntary labeling claims, you may state in the labeling that the product meets specific national or international consensus standard(s). The labeling should clearly identify the standard by name or alphanumeric text, including the year published or other information to identify the specific standard. If you make a voluntary claim, it should be truthful and accurate. Note that a 510(k) submission may contain a declaration of conformity with any or all parts of a standard without an associated claim in the labeling.
If the label states that a product meets a specific standard, the product delivered to the customer should meet the standard. The manufacturer should have data on file to support these claims.
Although FDA does not require a lot number to be placed on glove packaging, it is industry practice for the package of medical gloves to bear a lot number. Lot numbers are useful for traceability for complaints or returned product. This number or code may identify the batch of compounded latex, the production lines, the production shift, and/or, if sterile, the sterilization run. Some international consensus standards require lot numbers for conformance. Gloves conforming to those standards should have lot numbers. The lot number should be visible on the outside of the immediate packaging.
Many manufacturers have started placing bar codes on cartons and on the bottom of dispenser boxes. FDA encourages the use of bar coding.
The following are examples and do not represent real products:
Example: Powdered Latex Patient Examination Glove Box, Top
|
ABC ® BRAND Powdered with absorbable dusting powder, U.S.P. Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
Single Use Only
|
Example: Powdered Latex Patient Examination Glove Box, Side
ABC ® BRAND
Powdered with absorbable dusting powder, U.S.P.
|
Example: Powder-Free Latex Patient Examination Glove Box, Top
ABC ® BRAND Lubricated with Silicone Single Use Only Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
|
Example: Powder-Free Patient Examination Glove Box, Side ( with voluntary expiration date and lot number)
ABC ® BRAND Lubricated with Silicone
|
Example: Powdered Vinyl Patient Examination Glove Box, Top
ABC ® BRAND
CONTENTS: 100 Gloves (by weight) Manufactured For: |
Example: Powdered Vinyl Patient Examination Glove Box, Side
ABC ® BRAND
Single Use Only
|
Example: Powdered Surgical Glove Unit Package
¯¯ PEEL DOWN TO OPEN ¯¯ ABC ® BRAND POWDERED LATEX Single Use Only CONTENTS: One Pair (2 Gloves) SIZE: 7 Powdered with absorbable dusting powder Do NOT use if packaging is damaged.
|
A Premarket Notification (510(k)) is a submission of information sent to the FDA to obtain marketing clearance for a medical device. A 510(k) submission is a comparison of a new device with a “predicate” device. A predicate device is a legally marketed device to which equivalence is established. The 510(k) documents that the new finished medical glove you wish to market is as safe and effective as a legally marketed medical glove in the U.S. You cannot market medical gloves in the U.S. until you receive a letter from FDA declaring the gloves substantially equivalent (21 CFR 807.100(a)(5)).
ASTM International (ASTM) has developed a number of medical glove related standards. CDRH has officially recognized many of these standards for premarket clearance purposes. Conformance to these standards is voluntary. (See Chapter 10 of this guidance for more information on voluntary standards.)
You should provide physical parameter and biocompatibility data obtained from tests and inspection of packaged and sterilized gloves (finished gloves). The 510(k) submitter should keep this documentation on file.
You can find detailed instructions for a 510(k) submission for patient examination gloves and surgeon’s gloves in Chapters 6 and 7, respectively.
A 510(k) submitter may choose from three types of Premarket Notification 510(k) submissions for marketing clearance: Traditional, Special, and Abbreviated. The
traditional 510(k) method is the original submission as provided in 21 CFR part 807. There are two optional alternatives to the Traditional 510(k) method for obtaining 510(k) marketing clearance under certain instances: Special 510(k) and Abbreviated 510(k). The Special 510(k) Device Modification utilizes certain aspects of the Quality System regulation to streamline 510(k) review; the Abbreviated 510(k) relies on the use of guidance documents, special controls (for class II devices), and recognized standards to facilitate 510(k) review. Additional information about the 510(k) submission process is available at http://www.fda.gov/cdrh/devadvice/314.html.
As of October 1, 2002, FDA charges a fee to review 510(k) submissions. This submission fee applies to Traditional, Abbreviated, and Special 510(k)s. FDA should receive payment on or before the time you submit the 510(k) submission. If the submitter has not paid all fees owed, FDA will consider the submission incomplete and will not accept it for filing. You should direct questions regarding user fees to the Division of Small Manufacturers, International and Consumer Assistance at 240-276-3150.
Additional information, including the current review fee for a 510(k), is available at http://www.fda.gov/cdrh/devadvice/314a.html.
For medical gloves, the indication for use is the same as the intended use. The information, data, and labeling claims in the entire 510(k) submission should support and agree with the Indications for Use statement. CDRH will attach the Indications for Use statement to the substantial equivalence letter that is sent to the submitter when the 510(k) is cleared.
We recommend one of the following statements or equivalent text as an indication for use statement.
Powdered Examination Gloves
A powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.Powder-Free Examination Gloves
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.Powdered surgeon's gloves
A powdered surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.Powder-free surgeon's gloves
A powder-free surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
For a special purpose glove, you should include additional text in the Indications for Use statement that covers the additional function of the glove as stated in your labeling. You should also indicate that it is an over-the-counter device.
Medical glove 510(k) submissions should include samples of the package labeling. Labeling does not need to be in final printed format; you may submit draft labeling. The final labeling should be consistent with the draft labeling you submitted in the 510(k). The final labeling should agree with your drawings for labeling and preprinted packaging in your Quality System device master record (21 CFR 820.181), and comply with other applicable requirements in the Act and regulations.
Labeling, labeling claims, and data should be consistent with the Indications for Use statement. If you make any specific claims for your gloves, you should include data to substantiate the claims in this format or in identified attachments. Puffery, ambiguous, or unsubstantiated claims such as super strong, extra thick, micro thin, super sensitive, or low protein, are not appropriate.
Powder used for lubricating examination gloves should meet the United States Pharmacopoeia (U.S.P.) monograph for absorbable dusting powder or be equivalent in terms of safety and effectiveness. The 510(k) should include the type, specifications, and source of powder or other donning lubricant used on the gloves. You should not use talc, cotton flock, and other non-absorbable materials as a lubricating, dusting, or donning powder. Lycopodium (club moss spores) and ground pine pollen are toxic and are not acceptable as powder on or in medical gloves.
Absorbable donning or dusting powder from powder manufacturers that have obtained an approved new drug application (NDA), abbreviated new drug application (ANDA), or premarket approval application (PMA) must be used on powdered surgeon’s gloves (21 CFR 878.4480). A list of firms with approved NDAs or PMAs for Surgical Dusting Powder is available at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm . Use Product Code “KGP” as the search term.
Premarket Notification 510(k) submissions for coated medical gloves should contain complete information about the composition and intended purpose of the coating used, e.g., ease of donning. The draft labeling should also contain any special or additional claims for the gloves due to the presence of the coating, e.g., “easier to don.”
For gloves that are labeled as sterile, FDA recommends that you provide sterilization information in accordance with “ Updated 510(k) Sterility Review Guidance K90-1” available at http://www.fda.gov/cdrh/ode/guidance/361.html . You should sterilize the gloves to a sterility assurance level (SAL) of 1 x 10 -6 using a sterilization cycle that has been validated in accordance with the Quality Systems requirements, 21 CFR part 820.
In accordance with 21 CFR 807.87(h), the Premarket Notification 510(k) submission must include either a 510(k) Summary or a 510(k) Statement:
510(k) Summary is a summary of the 510(k) in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence (21 CFR 807.92) .
510(k) Statement is a certification that the 510(k) holder will provide a copy of the entire 510(k) submission, excluding patient identifiers, trade secret, and confidential commercial information, to any person within 30 days of a written request (21 CFR 807.93). You may not charge requesters for a copy of the 510(k) submission.
You should make the choice between the 510(k) Summary and 510(k) Statement before you submit the 510(k). You may elect to change your choice between the summary or statement before FDA determines substantial equivalence. FDA will accept Summaries or amendments to Summaries until FDA issues a determination of substantial equivalence. After the determination, you cannot modify the 510(k) Summary or change your choice of a 510(k) Summary or 510(k) Statement. See 21 CFR 807.92(a).
Further information regarding the content of the 510(k) Summary or 510(k) Statement may be obtained at www.fda.gov/cdrh/devadvice/314312.html#link_7.
510(k) Summary
We provide the following supplemental information for 510(k) Summaries for medical gloves.
21 CFR 807.92(a)(2)
Examples:
Trade name - ABC ® Latex Examination Gloves
Common name - exam gloves
Classification name - patient examination glove21 CFR 807.92(a)(4)
You should describe any variations from the predicate device. For special purpose gloves, describe the special features.21 CFR 807.92(a)(6)
We recommend that you include a brief table of the measured parameters of your finished gloves compared to FDA-recognized consensus standards or equivalent methods. You should include data that show conformance with FDA biocompatibility, pinhole, powder residual and other specifications and recommendations and any other parameter for which you have a labeling claim.21 CFR 807.92(b)(2)
Clinical data is usually not needed for medical glove 510(k) submissions.21 CFR 807.92(b)(3)
We recommend that you state that your gloves meet the FDA-recognized consensus standard or equivalent method and meet your labeling claims and pinhole acceptable quality level (AQL) as shown by the data in 21 CFR 807.92(a)(6).
510(k) Statement
The statement should be on a separate letterhead page, clearly identified as “510(k) statement,” signed by the certifier, not a consultant to the 510(k) submitter, and should include the specific language provided in 21 CFR 807.93.
Premarket Notification 510(k) Statement
http://www.fda.gov/cdrh/manual/stmnt2.html
If you make a change to your gloves that significantly affects safety or effectiveness of the gloves, you must submit a new and complete 510(k) ( 21 CFR 807.81(a)(3)) . Examples of changes that may require a new 510(k) include adding or deleting powder; adding color, fragrance, or a claim to the labeling; or modifying an important process. FDA usually does not require a new 510(k) if a manufacturer only does more of an existing process, such as extra leaching or washing, and makes no claim or mention of this change on the product labeling.
Changes to patient examination gloves, labeling, packaging, and processes should meet the Quality System regulation at 21 CFR 820.40 and 820.70(b). You should make changes to surgeon’s gloves, labeling, packaging, and processes in accordance with Quality System regulation at 21 CFR 820.30, 820.40, and 820.70(b). If you do not need a new 510(k), you should document your decision and how you arrived at it in the device master record (21 CFR 820.181).
We recommend the following guidance document for additional information:
Deciding When to Submit a 510(k) for a Change to an Existing Device
http://www.fda.gov/cdrh/ode/510kmod.html
You may submit a “Special” 510(k) submission for a modification to an existing glove 510(k) held by the same submitter.
A 510(k) may be bought, sold, or transferred. FDA is not involved in transfers of ownership. The new owner should maintain information documenting the transfer of ownership of a 510(k), including any legal transactions that took place, in its 510(k) files.
The new owner should list the device according to 21 CFR part 807 and the previous owner should delete its device listing. Upon inspection of the firm or upon entry of glove shipments into the U.S., FDA may request a review of documentation of ownership. If the owner is not able to provide the information, FDA may request the owner to submit a 510(k). You may not distribute the gloves until FDA clears the new submission.
Note that neither a registration nor a listing proves 510(k) ownership. The new owner of the 510(k) should maintain files with documentation proving ownership of the 510(k).
To avoid problems when importing a device with a transferred 510(k) ownership, FDA recommends that a copy of the specific information relating to the ownership sale or transfer accompany all shipments to the United States. This could be a simple one-page document detailing the transfer transaction.
To substantiate a “powder-free” claim in your Premarket Notification (510(k)) submission, you should state whether the manufacturing process for the glove includes any powder, such as a former-release powder and/or a donning powder. If it does, you should provide:
If the entire manufacturing process does notinclude any former release or donning powder, then you only need to discuss items 4 and 5 in the above list.
Chemotherapy gloves are specialty medical gloves. We recommend that you use the 510(k) format for chemotherapy gloves provided later in this chapter. If you label patient examination gloves designed for handling chemotherapy agents as, “Tested for Use with Chemotherapy Agents," you should provide data to support the claim. Otherwise, labeling, donning powder or lubricant, protein, and powder-free specifications for chemotherapy gloves are the same as for examination gloves.
You should include in the 510(k) submission the results of a controlled scientific study completed on the finished device to substantiate the claim. Test data should show the gloves are chemically resistant and/or can resist the permeation of chemical agents. Chemical resistance includes resistance of the glove to swelling, degradation, or deformation. The test method for permeability determines the time for a hazardous liquid (including temperature and concentration, if necessary) to permeate the barrier membrane of the glove as well as the rate of penetration once the barrier has been breached.
Testing should utilize the actual chemicals to be encountered, using the finished product, under the expected in use conditions (i.e., length of exposure, chemical concentration, contact, and temperature). Supporting test data should include an explanation and/or method of selecting the chemicals tested, a comprehensive description of the test method used, the complete protocol, an analysis of test results, a discussion, and the conclusions.
Chemotherapy gloves should meet an appropriate ASTM standard or an equivalent consensus standard for medical gloves. Physical features, such as increased thickness and length, make them more suitable for the safe handling of chemotherapy agents (usually minimal thickness of 0.10 mm, minimal length of 270 mm).
Premarket Notification (510(k)) submissions for Chemotherapy gloves should contain:
Chemotherapy gloves should also undergo standard biocompatibility testing for medical gloves.
This section contains a suggested format for the submission of a Premarket Notification (510(k)) for patient examination gloves. FDA does not require this format, but you may use it as a guide for submitting the necessary information to FDA. The suggested format should increase the completeness and accuracy of your submission and may reduce the time needed for review of your submission.
Although a single 510(k) submission for colored, flavored, or scented gloves may include more than one color and/or flavor or scent, you should test each glove type separately, as a finished glove, for biocompatibility and all physical characteristics. Data for multiple types of gloves should be in separate attachments.
A 510(k) submission should be complete; that is, you should not reference information from a previous 510(k) submission.
We recommend that you identify all attachments with the topic and the submitter’s name, street address, phone, and fax numbers. You should number the pages in your submission and attachments and include a table of contents. Do not include unnecessary information such as copies of standards and details of test equipment.
Sample Format for a Premarket Notification 510(k) for Examination Gloves
We recommend that you follow the Abbreviated 510(k) format provided in the guidance document, "Format for Traditional and Abbreviated 510(k)s" available at http://www.fda.gov/cdrh/ode/guidance/1567.html The guidance document will help you create a complete 510(k). Pertinent elements of a 510(k) are reiterated below and are described in the guidance.
Executive Summary:
We recommend you that you provide an executive summary of the 510(k), which should include a concise description of the device, including the indications for use and concise summary for any performance testing in the submission. We recommend that you identify all variations (for example, various colors) of gloves covered in the 510(k) submission. If this submission is for a modification of a patient examination glove cleared by FDA for marketing, include the 510(k) number of the cleared glove.
Classification Information:
Device Class: Class I
Device Name: Patient examination gloves - 21 CFR 880.6250
Product Code
[ ] Latex - LYY [ ] Vinyl - LYZ [ ] Synthetic Polymer - LZA |
[ ] Nitrile - LZA [ ] Specialty - LZC [ ] Finger Cot - LZB |
If the glove is made of a polymer or other type of material. identify the material.
_________________________________________________
Device Description and Specifications (of your specific Latex or Synthetic "xxxx" Polymer Glove):
Overall Length:________mm minimum
Width: ________mm minimum (for medium glove)
Palm Thickness:________mm minimum
Finger Thickness: ________mm minimum
Tensile Strength:
before aging _____________ Mpa minimum
after aging _______________Mpa minimum
Ultimate Elongation:
before aging _____________% minimum
after aging ______________ % minimum
Pinhole AQL: ____________
If latex gloves:
Does the above data for your examination gloves meet all the current specifications listed under the ASTM standard D3578 or an equivalent consensus standard?
YES ___ NO ___ If NO, explain why in an identified attachment.
If vinyl:
Do the vinyl examination gloves meet all the current specifications listed under ASTM Specification D5250 or an equivalent consensus standard?
YES ___ NO ___ If NO, explain why in an identified attachment.
If synthetic polymer gloves:
Does the above data for your synthetic/polychloroprene examination glove meet all the current specifications listed under the applicable ASTM standard D3578, D6977, or a standard for gloves composed of the specific synthetic polymer/nitrile glove?
YES ___ NO ___ If NO, explain why in an identified attachment.
If nitrile gloves:
Does the above data for your nitrile examination glove meet all the current specifications listed under the applicable ASTM standard D6319 or an equivalent consensus standard?
YES ___ NO ___ If NO, explain why in an identified attachment.
Specialty, Chemotherapy Gloves:
For chemotherapy or other specialty gloves, include data in an identified attachment to demonstrate the gloves are safe and effective to support labeling claims. (See Chapter 4 for guidance on labeling of medical gloves intended for use with chemotherapy agents.)
Former Release Powder or Chemical:
(If none is used, state that no release powder or chemical is used. )
Release Powder
or Chemical: _____________________________________________________
Supplier : _______________________________________________________
Specifications: ____________________________________________________
Dusting or Donning Powder:
(If none, state "powder-free")
Note: ASTM standards do not allow talc on the surface of medical gloves. Lycopodium (club moss spores) and ground pine pollen are toxic and are not acceptable as powder on or in medical gloves.
U.S.P. Absorbable Dusting Powder used?
YES _____ NO _____
If non-U.S.P. absorbable dusting powder is used, provide the following:
Powder Type: ____________________________________________________
Supplier:_________________________________________________________
Brand Name:_____________________________________________________
Specifications: ___________________________________________________
Weight of Donning Powder:
Weight of all types of powder on finished powder glove _____ +/- ____ milligrams per dm2 . Powder should be measured by ASTM D6124 or an equivalent test method.
Weight of Residual or Trace Powder Residue on “Powder-free” Gloves:
Weight of all types of residual or trace powder on finished powder-free glove _____ +/- _____ mg per glove determined by ASTM D6124. The weight of trace powder should not exceed 2 mg per glove or the limit in the ASTM standard.
If the gloves are powder-free, and the process includes any mold/former release or donning powder, we recommend that you provide the following:
Describe the powder(s) introduced at any stage of the glove manufacturing process.
In an identified attachment, describe in detail the process to remove the added powder(s).
In an identified attachment, include and describe the finished glove release specification supporting the "powder-free" claim and a brief summary of final product testing to ensure finished gloves meet this specification. (You should use the ASTM D6124 method or an equivalent method for measuring residual or trace powder.)
If the gloves are powder-free and the manufacturing process does NOT include any powder, we recommend that you provide the following.
Describe in an identified attachment how the glove is designed or manufactured to compensate for the lack of donning powder, or reasons why compensation is not necessary, including a full chemical characterization (e.g., chemical identity, specifications, biocompatibility) of any material used to facilitate glove donning, such as silicone or polymer coating on the glove. If a donning lubricant is used, state the composition and include biocompatibility data for the lubricant in an identified attachment; also state the name, manufacturer, and address below:
Lubricant
Generic Name: _____________________________________________________
Lubricant
Brand Name(s): _____________________________________________________
Chemical Name: ___________________________________________________
Lubricant
Manufacturer: _______________________________________________________
Address: ___________________________________________________________
___________________________________________________________
We recommend you certify that your finished "powder-free" gloves meet the following:
Protein Level of Natural Rubber Latex Gloves:
Protein level as measured by a standard method recognized by FDA _________________ mcg/dm2.
Was a Standard Test Method used to determine the protein level?
YES _____ NO_____
Specify the Standard Test Method used,
including the year _____________________
If no, include a complete description of the test method used and data showing how it correlates with a recognized standard method. You may check the CDRH website for a list of currently recognized standard test methods. The searchable standards database is available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
The protein testing was performed on the finished gloves that have undergone real time aging or accelerated aging per ASTM D3578:
YES _____ NO _____
We recommend that you include a summary of test results from samples of at least one lot of gloves that supports your stated protein level.
Protein Control:
We recommend that you specify what test will be used for determining protein content during routine production: ____________________.
If this is not a Standard Test method, please provide data correlating the routine quality control method to a recognized standard test method.
Chemical Sensitivity Claim:
If your labeling makes claims regarding the reduced potential of chemical sensitization or reduced reaction-inducing potential of your gloves in allergic individuals, you should provide supporting data in an identified attachment . We recommend the attachment present a summary of the data from appropriate testing.
Other Claims:
List any other claims that need supporting data and provide the data.
List in a table format the appropriate assay and timeframe for the evaluation that you used for each of the claims.
Color, Scent or Flavor Additives:
You should identify any color, scent, or flavor additive used in manufacturing medical gloves. You should provide the chemical name and composition of the color, scent, or flavor additive used and include biocompatibility data to support safe use of the additive.
Labels, Labeling, and Advertising:
The proposed labeling should include basic information (21 CFR 801) and appropriate caution statements. We recommend that you include identified copies of all labeling or proposed labeling, including promotional literature.
Sterility:
Are these examination gloves labeled as sterile?
YES _____ NO _____
If YES, state sterilization method (radiation, gas, etc.) used:
________________________________________
Sterility Assurance Level (SAL): ______________________________________
The SAL is the statistical probability of a glove not being sterile after going through the validated sterilization cycle. The SAL should be 10 -6 or better for a sterile glove.
Provide the method used to validate the sterilization cycle. Validation data is not required to be submitted in the 510(k).
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
If Radiation sterilization, dose in Kilograys ________________
If EtO Sterilization, reference the methods for determining residues and state the level of residue in parts per million (PPM):
Test Methods _________________________________
Ethylene Oxide ________________________________
Ethylene Chlorohydrin __________________________
Describe packaging used to maintain sterility:
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Sterilizer:
Name_____________________________________________________________
Street Address___________________________________________________________
Country___________________________________________________________
Phone No. ________________________ Fax No. _______________________
Registration Number of Sterilizer: _____________________________________
If sterilization is done by a contractor, the glove manufacturer should have a contract with the contract sterilizer that meets the specifications of 21 CFR 801.150(e). An importer may need two written agreements: one with the foreign manufacturer and a second agreement with the contract sterilizer.
Expiration Date:
If you want to include an expiration date on the labeling of the gloves covered by this 510(k) submission, specify the length of the expiration period in months and years for which you have valid supporting data. You should maintain data that supports expiration dating of the gloves.
Biocompatibility:
You should evaluate the biocompatibility of finished gloves and submit the result in an identified attachment. You should cite the specific test methods used and state the results obtained, i.e., “under conditions of the tests, the finished sterile gloves were not (or were) sensitizing and were not (or were) irritating.”
Please refer to 510(k) Format Tips available at http://www.fda.gov/cdrh/devadvice/314311.html for additional tips on the format of a 510(k) submission.
Powder-free surgeon’s gloves may be lubricated with small amounts of silicone or other suitable lubricant or be coated with a non-tacky polymer. A Premarket Notification (510(k)) submission should include a full characterization of the lubricant or coating such as the chemical identity, specifications, and biocompatibility.
This section contains a suggested format for the submission of a Premarket Notification (510(k)) for surgeon’s gloves. FDA does not require this format; however, you may use it as a guide for submitting the information to FDA. This format should increase the completeness and accuracy of your submission and reduce the time needed for review of your submission.
Although a single 510(k) submission for colored, flavored, or scented gloves may include more than one color and/or flavor or scent, you should test each glove type separately as a finished glove, for biocompatibility and all physical characteristics. Data for multiple types of gloves should be in separate attachments.
The person having direct or contractual control over sterilization should submit the 510(k) for surgeon’s gloves. If the manufacturer does the sterilization or contracts for the sterilization, the manufacturer submits the 510(k). For imported prelabeled “sterile” but not-yet-sterilized surgeon’s gloves, the importer that contracts for the sterilization should submit the 510(k) to FDA. However, the submitter should identify the manufacturer of the gloves in the submission.
A 510(k) submission should be complete; that is, you should not reference information from a previous 510(k) submission.
We recommend that you identify all attachments with the topic and the submitters name, street address, phone, and fax numbers. You should number the pages in your submission and attachments and include a table of contents. Do not include extraneous information such as copies of standards and details of test equipment.
Sample Format for a Premarket Notification (510(k)) for Surgeon’s Gloves
We recommend that you follow the Abbreviated 510(k) format provided in the guidance document, "Format for Traditional and Abbreviated 510(k)s" available at http://www.fda.gov/cdrh/ode/guidance/1567.html The guidance document will help you create a complete 510(k). Pertinent elements of a 510(k) are reiterated below and are described in the guidance.
Executive Summary:
We recommend you that you provide an executive summary of the 510(k), which should include a concise description of the device, including the indications for use and concise summary for any performance testing in the submission. We recommend that you identify all variations (for example, various colors) of gloves covered in the 510(k) submission. If this submission is for a modification of a surgeon’s glove cleared by FDA for marketing, include the 510(k) number of the cleared glove.
Classification Information:
Device Class: Class I
Device Description of Substantially Equivalent Device:
Surgeon’s gloves - 21 CFR 878.4460
Type: (check one)
[ ] Type 1 - gloves compounded primarily from natural rubber latex, or
[ ] Type 2 - gloves compounded primarily from rubber cement or synthetic rubber latex.
Product Code: ( check one )
[ ] Surgeon’s Glove - 79KGO
[ ] Glove Liners - 79KGO
[ ] Autopsy Gloves – 79KGO
Composition of Gloves: ( check one)
[ ] Latex
[ ] Latex Polymer Coated
[ ] Synthetic Polymer
[ ] Co-Polymer
[ ] Other, specify polymer(s) below, including any amount of natural rubber latex:
Describe polymer or “other”:____________________________________________________
Device Description and Specifications:
Overall Length: ________ mm minimum
Width: ________ mm minimum (for medium glove)
Palm Thickness: ________ mm minimum
Finger Thickness:________ mm minimum
Tensile Strength:
before aging _____________ Mpa minimum
after aging _______________Mpa minimum
Ultimate Elongation:
before aging _____________% minimum
after aging ______________ % minimum
Pinhole AQL: ____________
If latex gloves:
Does the above data for your latex surgeon’s gloves meet all the current specifications listed in the ASTM standard D3577 or an equivalent consensus standard?
YES ____ NO ____
If NO, explain why in an identified attachment and state the equivalent standard to which your gloves conform.
If synthetic polymer gloves:
Does the above data for your polymer surgeon’s gloves meet all the current specifications listed under ASTM standard D3577 or an equivalent standard for gloves composed of the specific synthetic polymer?
YES ____ NO ____
If NO, state the glove composition and all of your specifications in an identified attachment; and state the equivalent standard to which your gloves conform.
Specialty Surgeon’s Gloves:
If the submission contains a special claim, include data in an identified attachment to show that the specialty surgeon’s gloves are safe and effective for the special claim.
Former Release Powder or Chemical:
(If none is used, state that no release powder or chemical is used.)
Release Powder
or Chemical: _____________________________________________________
Supplier : _______________________________________________________
Specifications: ____________________________________________________
Absorbable Dusting or Donning Powder:
(If none, state “powder-free.”)
Note: ASTM standards do not allow Talc on the surface of medical gloves.
NDA, ANDA or PMA number: ______________________________________
Supplier:_________________________________________________________
Address:_________________________________________________________
Brand Name:_____________________________________________________
Specifications: ___________________________________________________
For Finished Powdered Gloves:
Weight of all types of powder on a glove _______ +/- _______ milligrams per dm2. Powder should be measured by ASTM D6124 or an equivalent test method.
Weight of Residual or Trace Powder Residue on “Powder-free” Gloves:
Weight of all types of residual or trace powder on finished powder-free glove _____ +/- _____ mg per glove determined by ASTM D6124. The weight of trace powder should not exceed 2 mg per glove or the limit in the ASTM standard.
If the gloves are powder-free and the process includes any mold / former release or donning powder, then the applicant should provide items 13.1 through 13.5 below. If the gloves are "powder-free" and the manufacturing process does NOT include any powder, then the applicant should complete items 13.4 and 13.5 below.
Describe the powder(s) introduced at any stage of the glove manufacturing process.
In an identified attachment, describe in detail the process to remove the added powder(s).
In an identified attachment, include and describe the finished glove release specification supporting the "powder-free" claim and a brief summary of final product testing to ensure finished gloves meet this specification. (You should use the ASTM D6124 method or an equivalent method for measuring residual or trace powder.)
Describe in an identified attachment how the glove is designed or manufactured to compensate for the lack of donning powder, or reasons why compensation is not necessary, including a full chemical characterization (e.g., chemical identity, specifications, biocompatibility) of any material used to facilitate glove donning, such as silicone or polymer coating on the glove. If a donning lubricant is used, state the composition and include biocompatibility data for the lubricant in an identified attachment; also state the name, manufacturer, and address below:
Lubricant
Generic Name: ______________________________________________________
Lubricant
Brand Name(s): _____________________________________________________
Chemical Name: _____________________________________________________
Lubricant
Manufacturer: _______________________________________________________
Address: ___________________________________________________________
___________________________________________________________
We recommend that you should certify that your finished sterile “powder-free” gloves meet ASTM D3577 standard or an equivalent standard for latex and polymers.
Protein Level of Natural Rubber Latex Gloves:
State the protein level as measured by a standard method recognized by Center for Devices and Radiological Health (CDRH) _________________ mcg/dm2.
Was a Standard Test Method used to determine the protein level?
YES _____ NO_____
Specify the Standard Test Method used,
including the year _____________________
If no, include a complete description of the test method used and data showing how it correlates with a recognized standard method. You may check the CDRH website for a list of currently recognized standard test methods. The searchable standards database is available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
The protein testing was performed on the finished gloves that have undergone real time aging or accelerated aging per ASTM D3577:
YES _____ NO _____
We recommend that you include a summary of test results from samples of at least one lot of gloves that supports your stated protein level.
Protein Control:
Specify what test will be used for determining protein content during routine production: ____________________.
If this is not a Standard Test method, include data correlating the routine quality control method to a recognized standard test method.
Chemical Sensitivity Claim:
If your labeling makes claims regarding the reduced potential of chemical sensitization or reduced reaction-inducing potential of your gloves in allergic individuals, you should provide supporting data in an identified attachment. We recommend the attachment present a summary of the data from appropriate testing.
Other Claims:
List any other claims that need supporting data and provide the data.
List in a table format the appropriate assay and timeframe for the evaluation that you used for each of the claims.
Color, Scent, or Flavor Additives:
You should identify any color, scent, or flavor additive used in manufacturing medical gloves. You should provide the chemical name and composition of the color, scent, or flavor additive used and include biocompatibility data to support safe use of the additive.
Labels, Labeling, and Advertising:
The labeling should include basic information (21 CFR part 801) and appropriate caution statements. We recommend that you include identified copies of all labeling or proposed labeling, including promotional literature. If the gloves are powdered, labeling should include the statement, “Powdered with Absorbable Dusting Powder.”
Sterility:
State sterilization method (radiation, gas, etc.) used:___________________________________
Sterility Assurance Level (SAL): ___________
The SAL is the statistical probability of a glove not being sterile after going through the validated sterilization cycle. The SAL should be 10-6 or better for a sterile glove.
Provide the method used to validate the sterilization cycle. Validation data is not required to be submitted in the 510(k). ___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
If radiation sterilization, dose in Kilograys: ________________
If EtO sterilization, reference the methods for determining residues and state the level of residue in parts per million (PPM):
Test Methods __________________________
Ethylene Oxide ________________________________
Ethylene Chlorohydrin __________________________
Describe packaging used to maintain sterility:
