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Surgical Face Mask

by Rizhao Sanqi Medical & Health Articles Co., Ltd.

510(k) K202903

Active European Union and United States

CE MDD 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) K202903↗

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 NumberK202903 Date24 Mar 2022ClearedStatusActive
European UnionCE/MDD 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  • Withdrawn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/MDD 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.

The Surgical Face Mask is a disposable barrier device designed to protect the wearer’s nose and mouth from contamination by airborne particles, splashes, sprays, or droplets. It is classified as a surgical mask under regulatory definitions, providing a physical barrier to reduce exposure to pathogens and airborne hazards in clinical and procedural settings.

This device is intended for single-use and is supplied in sterile packaging to ensure contamination control. It is manufactured under FDA 510(k) clearance (K202903) and complies with the Medical Device Directive (MDD). The mask is available in standard sizes and must be stored in a clean, dry environment to maintain sterility before use.

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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 Surgical Face Mask in clinical settings?

    This Surgical Face Mask is designed as a disposable barrier device to protect the wearer’s nose and mouth from airborne particles, splashes, sprays, or droplets. It acts as a physical barrier to reduce exposure to pathogens and airborne hazards, making it suitable for use during clinical procedures and medical settings where contamination control is critical.

  • Is this mask intended for reuse, or is it meant to be used only once?

    The Surgical Face Mask is explicitly designed for single-use only. This ensures optimal hygiene and sterility, as reusing it could compromise its protective barrier function and increase the risk of contamination.

  • How should I store this mask before use to ensure it remains sterile?

    The mask is supplied in sterile packaging, so it must be stored in a clean, dry environment to preserve sterility. Avoid exposing it to moisture, direct sunlight, or extreme temperatures, as these conditions could compromise its integrity before use.

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

    This Surgical Face Mask has undergone FDA 510(k) clearance (K202903) and complies with the Medical Device Directive (MDD). The clearance confirms it meets U.S. safety and performance standards for surgical masks, while MDD compliance ensures it aligns with European medical device regulations. These approvals validate its suitability for clinical use in both markets.

  • Are there different sizes available for this mask, and how do I know which one to choose?

    The mask is available in standard sizes, though the exact sizing options are not detailed in the provided data. Typically, surgical masks are designed to fit most adult faces, but if multiple sizes are offered, the packaging or manufacturer’s instructions should specify dimensions (e.g., length, width) to ensure a proper seal. Always verify fit to prevent gaps that could reduce protection.