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This guidance supersedes Draft Guidance for Industry and FDA Reviewers on the Content and Format of Premarket Notification [510(k)] Submissions for Surgical Mask issued January 16, 1998.

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Meets EN14683 Rating Type II Standard. LOW PERFORMANCE Surgical Molded Utility Mask Physical Barrier Only No LEVEL Performance Level ** Filtration Efficiency N/A ** Unless mask manufacturer certifies that the mask meets LEVEL performance Level 1 Ideal as a comfortable substitute for earloop face masks,

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