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Disposable Surgical Face Mask

by Anhui Cleanpro Pharmpack Co., Ltd.

510(k) K211696

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 NumberK211696 Date30 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  • Withdrawn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, 25 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 Surgical Face Mask is a piece of surgical apparel designed to cover the nose and mouth. It functions as a protective barrier for use in medical settings.

This device is regulated under 21 CFR 878.4040 and has received FDA 510(k) clearance. It is identified by K-number K211696 and product code FXX.

Questions

AI-generated answers, 25 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 surgical mask?

    This device is designed to serve as a protective barrier for the nose and mouth. It is intended for use in medical settings to provide coverage for the wearer.

  • What is the regulatory status of this device?

    This mask has received FDA 510(k) clearance under K-number K211696. It is regulated under 21 CFR 878.4040 and is classified under product code FXX.

  • Who is the manufacturer of this surgical mask?

    The device is manufactured by Anhui Cleanpro Pharmpack Co., Ltd., located in the Yeshan Industrial Zone in Tianchang, China.