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N95 Respirators and Surgical Masks (Face Masks) | FDA

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Surgical Masks - Premarket Notification [510(k)] Submissions

This guidance supersedes “Draft Guidance for Industry and FDA Reviewers on the Content and Format of Premarket Notification [510(k)] Submissions for Surgical Mask” issued January 16, 1998.

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Product Classification - Food and Drug Administration

6-254 ASTM F2100-11 (Reapproved 2018) Standard Specification for Performance of Materials Used in Medical Face Masks; 6-335 ASTM F2101-14 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus

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All personal protective equipment (PPE) that is intended for use as a medical device must follow The FDA's regulations and should meet applicable voluntary consensus standards for protection.

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Device Classification Panels | FDA

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Product Classification - Food and Drug Administration

Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892. If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892 , a premarket notification application and fda clearance is not required before marketing the device in the U.S. however ...

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