Biocompatibility tests required for examination and surgical gloves (latex and nitrile)
Biocompatibility testing is one of the critical section 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
FDA publish all 510k clearance on fda website, you can find substantial equivalence letter at www.fda.gov. Below are examples of examination and surgical glove 510k clearance letter
- Premarket Notification(510k)
- Establishment Registration
- Medical Device Labeling
- UDI submission
- ISO 13485 certification
- CE Marking
- 21 CFR 820