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Disposable Surgical Mask/Fluid Resistant Procedure Mask

by Lhm Medical Technology (Hong Kong) Limited

510(k) K202240

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) K202240↗

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 NumberK202240 Date25 Feb 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  • Withdrawn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
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 Surgical Mask/Fluid Resistant Procedure Mask, classified under the nomenclature for protective face masks designed to prevent contamination from respiratory droplets and splashes. It provides barrier protection for healthcare personnel during surgical procedures and patient isolation, adhering to fluid resistance standards for clinical environments.

The mask is supplied as a single-use, sterile item and is intended for use in surgical settings or patient isolation to protect both the wearer and patient from potential contaminants. It complies with regulatory requirements under FDA 510K clearance and MDR, ensuring compliance with fluid resistance standards such as ASTM Level 3 and EN 14683 Type IIR. Storage and handling must follow sterile medical device protocols to maintain integrity.

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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 types of clinical environments is this mask designed for, and how does it protect the wearer?

    This mask is specifically designed for surgical settings and patient isolation to protect healthcare personnel from respiratory droplets and splashes. It provides fluid-resistant barrier protection (compliant with ASTM Level 3 and EN 14683 Type IIR standards), shielding the wearer from potential contaminants during procedures where contamination risk is high.

  • Is this mask reusable, or is it intended for single-use only? How should it be stored to maintain sterility?

    This mask is explicitly labeled as single-use only and supplied in a sterile package. To preserve sterility, storage must follow sterile medical device protocols—keep the sealed packaging intact, store in a clean, dry environment away from direct sunlight or extreme temperatures, and avoid contamination from dust or moisture.

  • What regulatory standards does this mask meet, and how does that translate to its performance?

    The mask meets FDA 510K clearance and MDR (Medical Device Regulation) compliance, ensuring it adheres to fluid resistance standards like ASTM Level 3 (for splash protection) and EN 14683 Type IIR (for surgical use). These certifications validate its ability to block contaminants effectively in high-risk clinical scenarios.

  • Are there different sizes or models available, or is this a one-size-fits-all design?

    The provided data does not specify multiple sizes or models—this mask is described as a standard disposable surgical mask/fluid-resistant procedure mask without variations. If sizing flexibility is required for patients or wearers, additional models may exist outside the documented specifications, so verifying with the manufacturer would be advisable.