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This guidance supersedes “Draft Guidance for Industry and FDA Reviewers on the Content and Format of Premarket Notification [510(k)] Submissions for Surgical Mask” issued January 16, 1998.

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May 18, 2018 · The FDA finalized a rule this week exempting specific disposable respiratory protective masks from 510(k) requirements, according to a Regulatory Affairs Professionals Society report. The …

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The ‘N95’ designation means that when subjected to careful testing, the respirator blocks at least 95 percent of very small (0.3 micron) test particles. If properly fitted, the filtration capabilities of N95 respirators exceed those of face masks.

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