Tests Required for Surgical Face Masks — FDA 510(k)
Complete list of tests required for FDA 510(k) clearance of surgical face masks per ASTM F2100 and ISO 10993.
Liberty Management GroupSince 2009
The following tests are required for FDA 510(k) clearance of surgical face masks:
- Bacterial Filtration Efficiency (BFE) — ASTM F2101 (≥95 % for level 1, ≥98% for Level 2/3)
- Fluid Resistance — ASTM F1862 (synthetic blood penetration at 80/120/160mmHg – For level 1, 2,3)
- Differential Pressure (EN 14683:2019 Annex C)<5.0, <6.0, <6.0 mm H₂O/cm²- For level 1, 2,3
- Flammability — 16 CFR Part 1610 Class 1
- Biocompatibility — ISO 10993 (cytotoxicity, sensitization, irritation)
- Particulate Filtration Efficiency (PFE) — ASTM F2299 – ≥95 % for level 1, ≥98% for Level 2/3
- Packaging integrity and sterility for sterile masks
LMG assists surgical face mask manufacturers with test planning and complete 510(k) submission preparation (eSTAR format).
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- FDA Labeling Requirements for Surgical Face Masks
- Biocompatibility Tests for Surgical Face Masks
- Contents of Surgical Face Mask
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- FDA Premarket Approval PMA
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