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Procedure face mask (Model: KKF-2A)

by Han Zhaoqing Sporting Goods Company Limited

510(k) K202314

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 NumberK202314 Date13 Jan 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  • Withdrawn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, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

A procedure face mask is a device intended to be worn by healthcare personnel during procedures to protect both the patient and the wearer from the transfer of microorganisms, body fluids, and particulate material. This specific model, KKF-2A, is a procedure face mask as defined by its device name and specifications.

The device is supplied non-sterile and is intended for single-use. It is used in general healthcare settings, including plastic surgery environments, as indicated by the advisory committee classification. The mask has received FDA 510(k) clearance under K-number K202314 and is manufactured by Han Zhaoqing Sporting Goods Company Limited in Zhaoqing, Guangdong, China.

Questions

AI-generated answers, 21 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 Procedure face mask KKF-2A used for?

    The Procedure face mask KKF-2A is intended to be worn by healthcare personnel during procedures to protect both the patient and the wearer from the transfer of microorganisms, body fluids, and particulate material, as specified in its device description.

  • Is the Procedure face mask KKF-2A sterile or non-sterile, and is it reusable?

    The Procedure face mask KKF-2A is supplied non-sterile and is intended for single-use only, meaning it should not be reprocessed or reused after initial use, as stated in the device specifications.

  • In what settings is the Procedure face mask KKF-2A intended to be used?

    The Procedure face mask KKF-2A is used in general healthcare settings, including plastic surgery environments, as indicated by its advisory committee classification under General, Plastic Surgery.