KNH Surgical Face Mask

by Knh Surgical Face Mask

510(k) K203528

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

510(k) K203528↗

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK203528	Date16 Nov 2022Cleared	StatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K203528
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, 19 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 KNH Surgical Face Mask is a disposable surgical mask classified under product code FXX, designed to protect both patients and healthcare workers from the transfer of microorganisms, body fluids, and particulate matter. It is intended for use in general surgical settings and adheres to FDA standards for surgical face masks.

This device is supplied in a non-sterile form and is intended for single-use only. It is regulated under FDA 510(k) clearance (K203528) and is manufactured by Knh Surgical Face Mask, Tainan, Taiwan. The mask features elastic ear loops for secure fit and is available in standard dimensions.