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510K Summary - Food and Drug Administration

KG 300 Face Mask Device Common names Mask, surgical Device Product FXX, Class 11 Codes and Mask, surgical (21 CFR 678.4040) Classification Names: Predicate Devices The Kimberly-Clark KC100 face mask(s) subject of K1 10455. The Kimberly-Clark Face Mask(s) is a four layer mask,

File Size: 144KB

Search the Releasable 510(k) Database | FDA

You can search the releasable 510(k) database by Panel, 510(k) number, Product code or Device name. A search query will produce information from the database in the following format:

Missing:

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En14683 FDA510K Disposable Non-Woven Surgical Face Mask for Hospital, bacterial filtration efficiency (BFE%) > 99%. We provide excellent OEM services according to customer’s request. Only focus on high-quality personal production products for the benefit of human health.

Submitter's Identification: DEC 2 1 2012

Premrarket Notification -510(k) Submission -K122717 Tiger Medical -SUMMARY 510(K) Summary 7 - This summary of 510(K) is being submitted in accordance with the requirements of 21 CFR 807.92. 1. Submitter's Identification: DEC 2 1 2012 Tiger Medical Products Ltd.

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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 510k en14683 disposable surgical masks. Description: Surgical Masks Premarket Notification [510(k This guidance supersedes “Draft Guidance for Industry and FDA Reviewers on the Content and Format of Premarket Notification [510(k)] Submissions for Surgical Mask” issued January 16, 1998.

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Surgical Face Masks Compliance & Quality Control

A2 USA: Surgical Masks - Premarket Notification [510(k)] Submissions | FDA-2003 -D-0305 EU : Surgical (medical) mask – CE marking required | Regulation (EU) 2017/745 Q3 I do not have CE marking registration, can I still supply to EU market?

Recognized Consensus Standards

1.4 This test method does not address breathability of the medical face mask materials or any other properties affecting the ease of breathing through the medical face mask. This test method evaluates medical face masks as an item of protective clothing.

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