Biocompatibility Tests required for Surgical face masks

Biocompatibility testing is one of the major sections in FDA 510k submission for surgical masks. FDA review both the biocompatibility test protocol and biocompatibility test results. FDA will not clear the device to market in the USA, if the protocol used in biocompatibility testing is not approved even though the test result shows "passed". Also, the extraction ratio for the test item used in biocompatibility testing must comply with ISO 10993-12 standard.

Mandatory Test Tequirements for Surgical Face Masks

  • 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

LMG Provide assistance to surgical masks manufacturers in FDA registration, 510k clearance, device listing and US FDA Agent requirements.

Our experienced consultants can help you to comply with FDA requirements. Our expertise includes

  • Prepare 510k notification
  • Submission of 510k notification
  • FDA Agent service for 510k submission
  • Guidance in test requirements
  • Register your medical device establishment with FDA
  • List your surgical mask with FDA.

FDA Classification for Surgical Masks

Physical tests required for Surgical Masks

Contents of Surgical Masks 510k Notification

US FDA Medical Device Labeling Requirements - Surgical Masks

FDA 510K Clearance are public information, you can verify clearance status at FDA site. Below are examples of surgical mask 510k clearance.

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