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This guidance supersedes “Draft Guidance for Industry and FDA Reviewers on the Content and Format of Premarket Notification [510(k)] Submissions for Surgical Mask” issued January 16, 1998.

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510K Summary - Food and Drug Administration

Kimberly-Clark Face Mask(s) is a single use, disposable device, provided non- ste rile. Intended Use: The Kimberly-Clark, KC200 and K C300 Face Mask(s) is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.

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N95 Respirators and Surgical Masks (Face Masks) | FDA

N95 respirators and surgical masks (face masks) are examples of personal protective equipment that are used to protect the wearer from airborne particles and from liquid contaminating the face.

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FDAImports Blog » Bringing Face Masks to Market

Disposable surgical masks are FDA Class II devices, which require 510(k) clearance prior to importation and marketing in the US. This includes masks for use in sterile and non-sterile fields. In conjunction with meeting 510(k) requirements, there are labeling, facility registration, product listing, and U.S. Agency requirements to consider.

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Disposable Medical Face Mask - Chinese Face Mask Supplier

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FDA exempted certain class II surgical masks from ...

FDA exempted certain class II surgical masks from premarket notification requirements, subject to conditions and limitations (83 FR 22846). Specifically, single-use, disposable respiratory protective

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N95 Respirators and Surgical Masks (Face Masks) | FDA

N95 respirators and surgical masks (face masks) are examples of personal protective equipment that are used to protect the wearer from airborne particles and from liquid contaminating the face.

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FDA Lifts Requirements for Masks, Respirators, Looks to ...

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Masks and N95 Respirators | FDA

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