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This guidance supersedes “Draft Guidance for Industry and FDA Reviewers on the Content and Format of Premarket Notification [510(k)] Submissions for Surgical Mask” issued January 16, 1998.

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510K Summary - Food and Drug Administration

510(k) for ASTM F2100 Level 2 and Level 3 Face Mask(s) OC 202011o 510K Summary Date Summary was May 17, 2011 Prepared: 610(k) Submitter: Ann Waterhouse, RAC Associate Director of Regulatory Affairs Roswell, GA 30076 678-352-671 9 (telephone) 920-225-3108 (facsimile) Ann.waterhouse(&kcc Device Trade Name: KG 200 Face Mask KG 300 Face Mask

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The FDA also issued guidance outlining a policy to help expand the availability of general use face masks for the general public and respirators for health care professionals during this pandemic ...

Personal Protective Equipment for Infection Control | FDA

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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Guidance for Industry and FDA Staff . Surgical Masks - Premarket Notification [510(k)] Submissions . Document issued on: March 5, 2004 and a correction posted on July 14, 2004.

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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 …

Medical Gloves | FDA

Medical gloves are examples of personal protective equipment that are used to protect the wearer and/or the patient from the spread of infection or illness during medical procedures and examinations.

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