Biocompatibility tests required for examination and surgical gloves (latex and nitrile)

Biocompatibility testing is one of the critical sections in FDA 510k submission for gloves. FDA review both the test protocol and test results. FDA will not issue a substantial equivalence (SE) letter to your 510k notification if the protocol used in biocompatibility testing is not approved even though the test result shows "passed.”

Below are the mandatory test requirements for latex and examination gloves.

• ISO 10993-10 biological evaluation of medical devices Test for irritation
• ISO 10993-10 Biological Evaluation of Medical Devices Test for Skin sensitization
• ISO 10993-5 Biological evaluation of medical devices Test for in vitro cytotoxicity
• ISO 10993-11 Biological evaluation of medical devices Tests for systemic toxicity

Physical tests required for examination and surgical gloves

FDA Classification for examination and surgical gloves

US FDA Medical Device Labeling Requirements - Gloves

US FDA 510K Submission Format

Contents of examination and surgical gloves (Latex / Nitrile) 510k Notification

FDA publishes all 510k clearance on the FDA website; you can find substantial equivalence letters on the FDA website. Below are examples of examination and surgical glove 510k clearance.

FDA 510k Consultant for Nitrile Gloves

As your FDA 510k consultant, LMG will ensure that your biocompatibility tests are as per the approved protocol and that all the physical tests are as per the recommended standards. Most NSE decisions for the glove 510k’s result from using the incorrect standards for testing.

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