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Medical Face Mask

by Wuxi Yushou Medical Appliances Co., Ltd.

510(k) K210679

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K210679↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK210679 Date18 Jan 2022ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
FXX
Device Class
Class II
Regulation
21 CFR Part 878.4040
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a Medical Face Mask, classified under the product code FXX. It is designed to provide barrier protection against airborne particles, droplets, and splashes, helping to reduce the risk of infection transmission in clinical and public health settings. Constructed from medical-grade materials, it adheres to standards for respiratory protection and hygiene in healthcare environments.

The Medical Face Mask is supplied as a single-use, non-sterile disposable item, intended for one-time use per patient encounter. It is regulated under FDA 510(k) clearance (K210679) and EU MDR compliance, ensuring adherence to safety and performance requirements. Available in standard sizes, it is packaged individually for easy access and storage in healthcare facilities, hospitals, and public health settings.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of this Medical Face Mask and in which settings is it intended for use?

    This Medical Face Mask is designed to provide barrier protection against airborne particles, droplets, and splashes, helping to minimize infection transmission risks. It is intended for use in clinical and public health settings, such as hospitals, healthcare facilities, and public health environments where respiratory protection and hygiene are critical.

  • Is this face mask reusable, and if not, how many times can it be used?

    No, this face mask is explicitly labeled as a single-use item. It is intended for one-time use per patient encounter, meaning it should not be reused after a single application to ensure optimal protection and hygiene.

  • How is the mask packaged, and what storage considerations should be kept in mind?

    The mask is supplied individually packaged for easy access and hygiene. Since it is non-sterile and single-use, storage should be in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its integrity until use.

  • What regulatory pathways does this device follow, and how does that affect its use?

    This mask is regulated under FDA 510(k) clearance (K210679) and EU MDR compliance, ensuring it meets safety and performance standards. The FDA classification (FXX) and traditional clearance process confirm its suitability for barrier protection in healthcare settings, but compliance with local regulations (e.g., FDA or EU directives) must be followed for authorized use.