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U.S. Department of Health and Human Services

Medical Devices

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6. Patient Examination Gloves

POWDER-FREE

CHEMOTHERAPY GLOVES

FORMAT FOR PREMARKET NOTIFICATION 510(k)
 

POWDER-FREE

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:

  1. a description of the powder(s) introduced at any stage of the glove manufacturing process, such as former release or stripping powder and donning powder;
  2. a detailed description of the process to remove the added powder(s);
  3. a description of the release specification supporting the powder-free claim and a brief summary of the final product testing to ensure the glove meets this specification;
  4. a description of how the glove is designed or manufactured to compensate for the lack of donning powder, or reasons why the compensation is not necessary, including a full characterization such as the chemical identity, specifications, and biocompatibility of any material such as silicone added to the glove to facilitate glove donning; and
  5. a certification that the finished powder-free glove meets ASTM International (ASTM) standard D3577 (Standard Specification for Rubber Surgical Gloves), D3578 (Standard Specification for Rubber Examination Gloves), D5250 (Standard Specification for Poly(vinyl chloride) Gloves for Medical Application), or an equivalent standard, as appropriate.

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

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:

  • the product labeling that specifies the chemical(s) that the glove provide(s) protection against;
  • the results of a controlled scientific study to substantiate the claim,
  • a comprehensive description of the test method used,
  • the complete test protocol,
  • an analysis of test results,
  • a discussion as appropriate, and
  • conclusions.

Chemotherapy gloves should also undergo standard biocompatibility testing for medical gloves.

FORMAT FOR PREMARKET NOTIFICATION 510(k)

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". 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:

  • ASTM D3578 standard or equivalent standard for natural rubber latex,
  • ASTM D 5250 standard or an equivalent standard for vinyl, or
  • ASTM D6319 standard or an equivalent standard for nitrile.
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 for additional tips on the format of a 510(k) submission.