Tests required for latex and nitrile gloves - FDA Submission
Biocompatibility tests are mandatory sections in FDA 510k submission for examination and surgical gloves; in most cases, these tests are conducted in a third-party lab. Besides the biocompatibility testing, the below in-house tests are also required in 510k notification, and test results must comply with approved standards like ASTM and ISO.
- Shelf-life testing
- Glove dimension testing
- Physical property testing
- 1000 ml watertight testing
- Residual EO testing - for EO sterilized glove
- Protein content test - if protein content claim on glove label
FDA publishes all 510k clearance on the FDA website; you can find substantial equivalence letters at www.fda.gov. Below are examples of examination and surgical glove 510k clearance letters.