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U.S. Department of Health and Human Services

Medical Devices

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7. Surgeon's Gloves

POWDER-FREE

FORMAT FOR PREMARKET NOTIFICATION 510(k)

POWDER-FREE

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.

FORMAT FOR PREMARKET NOTIFICATION 510(k)

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". 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:

___________________________________________________________________________

___________________________________________________________________________

___________________________________________________________________________

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. Data should be maintained by the manufacturers to support expiration dating of their gloves. (See Chapter 4 for labeling guidance.)

Biocompatibility:

You should evaluate the biocompatibility tests on 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.