Biocompatibility Tests for Surgical Face Masks
Biocompatibility testing under ISO 10993 is required for FDA 510(k) clearance of surgical face masks. LMG guides mask manufacturers through required testing.
Biocompatibility Tests 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 Requirements for Surgical Face Masks
- 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
LMG assists surgical mask manufacturers in FDA registration, 510(k) clearance, device listing, and US FDA Agent requirements.
Our experienced consultants can help you to comply with FDA requirements. Our expertise includes
- Device classification
- Identification of required documents
- Guidance in test requirements
- Prepare 510(k) Notification
- 510(k) Notification submission (eSTAR)
- FDA agent service for 510k submission
- Register your medical device establishment with the FDA
- List your surgical mask with the FDA
FDA 510(k) Clearances are public information; you can verify clearance status at the FDA site. Below are examples of surgical mask 510(k) clearance.
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Contact Liberty Management Group for expert FDA regulatory consulting.
Contact LMG- Medical Device Establishment Registration
- Premarket Notification 510(k)
- FDA Registration for Surgical Face Masks
- Tests Required for Surgical Face Masks
- FDA Labeling Requirements for Surgical Face Masks
- Contents of Surgical Face Mask
- FDA Registration for Latex Nitrile Gloves
- FDA Premarket Approval PMA