Contents of Surgical Face Mask 510(k) Notification
Required contents of an FDA 510(k) notification for surgical face masks. LMG prepares complete surgical mask 510(k) submissions.
Surgical Face MasksFDA 510(k)50+ ClearancesSince 2009
An FDA 510(k) premarket notification for surgical face masks must contain the following sections:
- Device description — materials, layers, construction, intended use
- Predicate device comparison — substantial equivalence to a cleared surgical mask
- Performance testing — BFE (ASTM F2101), fluid resistance (ASTM F1862), differential pressure (EN 14683:2019 Annex C), flammability (16 CFR 1610)
- Biocompatibility data (ISO 10993) — cytotoxicity, sensitization, irritation
- Draft labeling — including ASTM F2100 performance level
- Packaging validation for sterile masks (ISO 11607)
- 510(k) summary
LMG prepares complete 510(k) submissions in eSTAR format for surgical face mask manufacturers worldwide.
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- Medical Device Establishment Registration
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- Tests Required for Surgical Face Masks
- FDA Labeling Requirements for Surgical Face Masks
- Biocompatibility Tests for Surgical Face Masks
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- FDA Premarket Approval PMA
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