Biocompatibility Tests for Examination & Surgical Gloves

Biocompatibility testing under ISO 10993 is required for FDA 510(k) clearance of examination and surgical gloves. LMG assists glove manufacturers in identifying required tests.

ISO 10993510(k) RequiredTest PlanningSince 2009

Required Biocompatibility Tests for Gloves

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”.

Required tests for gloves typically include:

ISO 10993-23 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 510k Consultant for 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.

FDA publishes all 510(k) clearances on the FDA website, where you can find the substantial equivalence letters. Below are examples of examination and surgical glove 510(k) clearances.