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U.S. Department of Health and Human Services

Medical Devices

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4. Labeling

BASIC LABELING

DEVICES THAT CONTAIN NATURAL RUBBER

EXPIRATION DATE LABELING

DONNING POWDER OR LUBRICANT IDENTIFICATION

ATTRIBUTE LABELING

STANDARDS

LOT NUMBER

BAR CODING

EXAMPLE LABELING
 

BASIC LABELING

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
  • The label of a glove should contain the name and place of business of the manufacturer, packer, or distributor, including the street, address, city, state, and zip code.
  • If the street address of the identified manufacturer, packer, or distributor is in the local ( U.S.) telephone directory, you can omit the street address. (21 CFR 801.1(a) and (d)).
  • If the firm identified on the label is not the manufacturer, then you should qualify the firm’s name by an appropriate statement such as, “Manufactured for...” or “Distributed by....” (21 CFR 801.1(c)).
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)
  • The statement of identity of the glove must be on the principal display panel. The “principal display panel,” means “…the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale.” (21 CFR 801.60).
  • If the glove is made of a synthetic polymer, the statement of identity should include the common, generic, or scientific name of the polymer used. The term "synthetic" used alone does not fully characterize the composition of the glove and may mislead the purchaser. If you manufacture the glove from a blend of polymers, you should identify each component, including any blend containing natural rubber latex.
  • The identity statement must list the common name of the device (21 CFR 801.61(b)). Examples include powdered latex surgeon’s gloves, powdered latex patient examination gloves, powder-free latex surgeon’s gloves, powder-free latex patient examination gloves, latex finger cots, powdered nitrile examination gloves, and powder-free vinyl examination gloves. You should not use undefined terms such as “low-powder.”
  • The identity statement must be in bold face type, reasonably related in size to the most prominent printed matter on the display panel, and in lines generally parallel to the base of the package when rested (21 CFR 801.61(c)).  
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.

DEVICES THAT CONTAIN NATURAL RUBBER

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

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:

  • Barrier property tests. You should perform the FDA 1000 mL Water Leak Test (21 CFR 800.20) or ASTM International (ASTM) D5151, Standard Test Method for Detection of Holes in Medical Gloves to assess barrier integrity.
  • Physical properties tests. You should use appropriate physical properties tests such as those in ASTM D3577, Standard Specification for Rubber Surgical Gloves; ASTM D3578, Standard Specification for Rubber Examination Gloves; ASTM D5250, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application; ASTM D6319, Standard Specification for Nitrile Examination Gloves for Medical Application; or an equivalent appropriate physical property test.
  • Sterility and package integrity tests. You should test sterile glove packaging for package integrity and the ability to maintain sterility. Documentation should include evidence that, after storage, the product packaging still meets the manufacturer’s specifications for package integrity.
  • Tests to support labeling claims . You should test for properties that may be adversely affected by product aging, such as resistance to chemicals. Manufacturers should document this testing.

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:

  • product identification, including lot numbers and date of manufacture
  • test method identification, including documentation for in-house procedures
  • sample size and acceptance criteria for each test conducted
  • description of product packaging during storage (e.g., individually packaged, standard sterile packaging)
  • description of storage environment (temperature and humidity) and duration of storage
  • time elapsed between date of manufacture and each testing interval
  • raw test data, including an appropriate statistical summary
  • data analysis
  • conclusion, including the shelf life supported by the data.
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:

  1. You can obtain the expiration date for a specific lot of gloves by adding the established shelf life to the date of manufacture for that lot. The “date of manufacture” refers to the date of completion of the final step of the manufacturing process (final packaging or sterilization).
  2. The expiration date should state the month and year of the shelf life. You should express the expiration date by spelling out the name of the month followed by the 4-digit year, e.g., January 2006. You should not express the date as 1/10/06 because this may be interpreted as October 1, 2006, in some parts of the world, resulting in the use of outdated and degraded gloves.
  3. The expiration date, stated as “Use Before: [date]” should be prominently displayed on the exterior of the primary and retail package and on the shipping carton.
  4. Sterile surgeon’s and patient examination gloves that have an expiration date based on sterility that is different from the expiration date based upon physical and mechanical integrity testing should bear only the earlier expiration date.

ASTM International developed the following standards for expiration dating of medical gloves:

  • D7160-05 Standard Practice for Determination of Expiration Dating for Medical Gloves
  • D7161-05 Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions

You can obtain more information on these standards directly from ASTM.

DONNING POWDER OR LUBRICANT IDENTIFICATION

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.”

ATTRIBUTE LABELING

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”. 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):

  • chemical resistance data (test method used, chemicals tested), for consumer review, if desired,
  • the statement, “Gloves used for protection against chemotherapy drug exposure should be selected specifically for the type of chemicals used,” and
  • instructions for users to review drug labeling or material safety data sheets for the chemicals being used to determine an adequate level of protection for the intended use.
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.

STANDARDS

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.

 LOT NUMBER

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.

BAR CODING

Many manufacturers have started placing bar codes on cartons and on the bottom of dispenser boxes. FDA encourages the use of bar coding.

EXAMPLE LABELING

The following are examples and do not represent real products:

Example: Powdered Latex Patient Examination Glove Box, Top

ABC ® BRAND
POWDERED LATEX EXAMINATION GLOVES

Powdered with absorbable dusting powder, U.S.P.

Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.

 

Single Use Only
Nonsterile

Distributed by: CONTENTS: 100 Gloves (by weight)

ABC Corporation
Boston, MA 10001
Lot # 03C2004

SIZE: MEDIUM


 

Example: Powdered Latex Patient Examination Glove Box, Side

 

ABC ® BRAND
POWDERED LATEX EXAMINATION GLOVES
CONTENTS: 100 Gloves (by weight) SIZE: MEDIUM
Powdered with absorbable dusting powder, U.S.P.
Single Use Only
Distributed by:    
ABC Corporation    
Boston, MA 10001 Product of Malaysia Lot: 03C2004

 

Example: Powder-Free Latex Patient Examination Glove Box, Top

 

ABC ® BRAND
POWDER-FREE LATEX EXAMINATION GLOVES

Lubricated with Silicone

Single Use Only

Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.

 

 

Manufactured For:
DSMICARES Inc.
Rockville, MD 20850 USA
 
CONTENTS: 100 Gloves (by weight)
SIZE: MEDIUM

 


Example: Powder-Free Patient Examination Glove Box, Side (
with voluntary expiration date and lot number)

 

 ABC ® BRAND
POWDER-FREE LATEX EXAMINATION GLOVES

Lubricated with Silicone
Single Use Only
CONTENTS: 100 Gloves (by weight)
SIZE: MEDIUM
Manufactured For:

DSMICARES Inc.   Use Before: Dec. 2006
Rockville, MD 20850 USA Product of Thailand Lot: 051199


Example: Powdered Vinyl Patient Examination Glove Box, Top

 

ABC ® BRAND
POWDERED VINYL EXAMINATION GLOVES
Powdered with absorbable dusting powder, U.S.P.
Single Use Only

 

 

CONTENTS: 100 Gloves (by weight)
SIZE: MEDIUM

Manufactured For:
Medical Art, Inc.
Terrell, MD 28888 USA


Example: Powdered Vinyl Patient Examination Glove Box, Side

 

ABC ® BRAND
POWDERED VINYL EXAMINATION GLOVES
CONTENTS: 100 Gloves (by weight) SIZE: MEDIUM
Single Use Only
Powdered with absorbable dusting powder, U.S.P.
Manufactured For:    
Medical Art, Inc.    
Terrell, MD 28888 USA Product of Taiwan Lot: 031100

 

Example: Powdered Surgical Glove Unit Package

 

 

¯¯ PEEL DOWN TO OPEN ¯¯

ABC ® BRAND

STERILE

POWDERED LATEX
SURGICAL GLOVES

Single Use Only
Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.

CONTENTS: One Pair (2 Gloves)

SIZE: 7

Powdered with absorbable dusting powder

Do NOT use if packaging is damaged.
 

Lot: S101000 Use Before: November 2006
   
Distributed by:
ABC Corporation
Big Apple, NY 10018
Product of Indonesia