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This guidance supersedes “Draft Guidance for Industry and FDA Reviewers on the Content and Format of Premarket Notification [510(k)] Submissions for Surgical Mask” issued January 16, 1998.

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No, an N95 full face mask would be required for that. Are these masks N95 rated? No, surgical masks are not N95 rated. ... Disposable 3-Ply Surgical Mask. ... Our Medical and Technical Team is committed to ensuring that Influenza Store meets the best international standards in all that we do. From the review of our day-to-day operations to ...

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