Skip to content

Disposable Medical Mask

by Hangzhou Qianzhiya Sanitary Products Co., Ltd

510(k) K202133

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) K202133↗

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 NumberK202133 Date25 Mar 2021ClearedStatusActive
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  • Withdrawn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
Hangzhou Qianzhiya Sanitary Products 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 Mask, classified under the nomenclature for protective respiratory devices. It is designed to provide barrier protection against airborne particles, splashes, and droplets, reducing the risk of contamination for both users and patients in clinical settings.

The mask is intended for single-use and supplied in sterile packaging. It complies with FDA 510(k) clearance under the Traditional pathway, classified as substantially equivalent to predicate devices. Authorised for use in general and plastic surgery environments, it adheres to MDR compliance standards and is manufactured by Hangzhou Qianzhiya Sanitary Products Co., Ltd.

Other devices from Hangzhou Qianzhiya Sanitary Products 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 clinical environments is this disposable medical mask authorized for use in according to its regulatory filings?

    This disposable medical mask is authorized for use in general and plastic surgery environments. The authorization is based on its classification under the FDA 510(k) pathway as substantially equivalent to predicate devices, specifically under product code FXX, which aligns with protective respiratory devices for surgical contexts.

  • Is this mask intended for reuse or single-use, and how is it packaged?

    This disposable medical mask is explicitly designed for single-use only, as stated in its description. It is supplied in sterile packaging to ensure contamination control before use, which is critical for maintaining hygiene in clinical settings.

  • What regulatory pathways does this mask comply with, and how does it meet compliance standards?

    The mask complies with both FDA 510(k) clearance under the Traditional pathway (K202133) and MDR (Medical Device Regulation) compliance standards. Its FDA authorization confirms it is classified as substantially equivalent to predicate devices, while MDR compliance ensures it meets European regulatory requirements for safety and performance.

  • How should this mask be stored to maintain its integrity before use?

    Since the mask is supplied in sterile packaging, it should be stored in a clean, dry environment away from direct sunlight, extreme temperatures, or moisture. The packaging seal must remain intact until use to preserve sterility and prevent contamination, as single-use devices rely on this protection.