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

Biocompatibility tests required for examination and surgical gloves

FDA Classification for examination and surgical gloves

US FDA Medical Device Labeling Requirements - Gloves

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

US FDA 510K Submission Format

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.

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