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Disposable Medical Face Mask DF3-001

by Wellmed Dental Medical Supply Co., Ltd

510(k) K222697

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) K222697↗

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 NumberK222697 Date4 Nov 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  • Withdrawn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
Wellmed Dental Medical Supply 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.

The Disposable Medical Face Mask DF3-001 is a single-use barrier device classified under the nomenclature code FXX. It is designed to protect both patients and healthcare personnel from exposure to microorganisms, body fluids, and airborne particulates, serving as a critical component of infection control protocols in clinical settings.

This device is supplied as a sterile, disposable item intended for one-time use. It complies with FDA 510(k) clearance (K222697) and EU MDR requirements, ensuring regulatory adherence for use in medical environments. The mask is non-reusable and must be stored in a clean, dry environment prior to use, with no specific MRI safety considerations noted. No additional sizes or variants are referenced beyond the model DF3-001.

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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.

  • Is this mask reusable or designed for single-use only, and how should it be stored before use?

    This mask is explicitly designed for single-use only and must not be reused. It is supplied sterile, so it should be stored in a clean, dry environment prior to use to maintain its integrity and sterility. Avoid exposing it to moisture or contamination before application.

  • What regulatory approvals does this mask hold, and how does that affect its use in clinical settings?

    The mask holds FDA 510(k) clearance (K222697) and complies with EU MDR requirements, confirming it meets regulatory standards for use in medical environments. These approvals validate its safety and effectiveness as a barrier device for infection control, ensuring it can be trusted in healthcare settings where protection from microorganisms and particulates is critical.

  • Are there different sizes or variants available for this model, or is it a one-size-fits-all design?

    The DF3-001 is supplied as a single model with no additional sizes or variants mentioned in the specifications. It is intended as a standardized disposable face mask, so users should confirm fit based on typical sizing guidelines for medical masks, though no specific adjustments are referenced beyond the base model.

  • Does this mask have any special handling requirements, such as MRI safety considerations, before or after use?

    There are no MRI safety considerations noted for this mask, meaning it does not contain metallic or ferromagnetic materials that could interfere with MRI procedures. However, since it is a single-use, disposable item, it should be discarded immediately after use and not reused or reprocessed.