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Disposable Medical Face Mask

by Zhejiang Senhong Medical&Instrument Co., Ltd.

510(k) K202676

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Traditional NumberK202676 Date5 Nov 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

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, 23 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 is a Class 2 general hospital device designed to provide a physical barrier. It is intended to be worn by healthcare personnel to protect both patients and staff from the transfer of microorganisms, body fluids, and particulate material.

This device is supplied as a single-use product. It has received FDA 510(k) clearance under the traditional pathway, identified by the reference number K202676. The mask is manufactured by Zhejiang Senhong Medical and Instrument Co., Ltd.

Questions

AI-generated answers, 23 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 intended use of this medical face mask?

    This device is designed as a physical barrier for healthcare personnel. It is intended to protect both patients and staff from the transfer of microorganisms, body fluids, and particulate material during clinical procedures.

  • Is this mask intended for multiple uses?

    No, this device is supplied as a single-use product. It should be disposed of after each use to maintain the integrity of the physical barrier and prevent cross-contamination.

  • What is the regulatory status of this device?

    This mask has received FDA 510(k) clearance under the traditional pathway, identified by the reference number K202676. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.