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Surgical Masks - Premarket Notification [510(k ...

This guidance supersedes “Draft Guidance for Industry and FDA Reviewers on the Content and Format of Premarket Notification [510(k)] Submissions for Surgical Mask” issued January 16, 1998.

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3ply surgical mask The bottom and surface of the product are made of non-woven fabrics with high efficiency filter material added in the middle and heated by …

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Medical Gowns | FDA

Surgical Gowns. A surgical gown is regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification. A surgical gown is a personal protective garment intended to be ...

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