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Disposable Medical Face Mask

by Xiantao Zhuobo Industrial Co., LTD

510(k) K223055

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) K223055↗

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 NumberK223055 Date5 Dec 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  • Withdrawn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
FDA applicant
Xiantao Zhuobo Industrial Co., Ltd.
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 Disposable Medical Face Mask, classified under the FDA Product Code FXX for general surgical and medical use. It is designed to provide a barrier against airborne particles, splashes, sprays, and droplets, helping to reduce the risk of infection in clinical and healthcare settings. The mask is intended for single-use and adheres to regulatory standards for disposable medical barriers.

The mask is supplied as a sterile, single-use item and is regulated under FDA 510K clearance (K223055) and MDR compliance. It is intended for use in environments requiring basic respiratory protection, such as outpatient clinics, hospitals, and surgical procedures. Storage should follow manufacturer guidelines to maintain sterility and integrity until use. No additional regulatory approvals beyond those stated are implied.

Other devices from Xiantao Zhuobo Industrial Co., LTD

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 types of clinical environments is this disposable face mask intended for use in?

    This disposable face mask is designed for general surgical and medical use, making it suitable for environments like outpatient clinics, hospitals, and surgical procedures where basic respiratory protection is required. Its purpose is to create a barrier against airborne particles, splashes, sprays, and droplets, helping to reduce infection risks in routine healthcare settings.

  • Is this face mask meant for reuse, or is it intended for single-use only?

    The mask is explicitly labeled for single-use only, meaning it should not be reused after one application. This aligns with standard practices for disposable medical barriers to ensure sterility and effectiveness in protecting both the wearer and patients.

  • How should I store this mask to maintain its sterility and usability?

    Storage instructions are provided by the manufacturer, but generally, disposable medical face masks like this should be kept in a clean, dry environment away from direct sunlight, extreme temperatures, or contaminants. The packaging should remain intact until use to preserve sterility and prevent damage to the barrier properties.

  • What regulatory pathways has this device followed, and what does that mean for its use?

    This mask has undergone FDA 510(k) clearance (K223055) under the Traditional pathway and complies with MDR (Medical Device Regulation) standards. The clearance confirms it is deemed *substantially equivalent* to a predicate device, ensuring it meets safety and performance requirements for its intended use as a disposable medical barrier in clinical settings.