Tests required for latex and nitrile gloves - FDA Submission

Biocompatibility testing's are mandatory sections in FDA 510k submission for examination and surgical gloves, most of the cases these tests are conducted on 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 water tight 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 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

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