Skip to content

Disposable Medical Surgical Mask

by Jiangxi Bestgrand Health Technology Co., Ltd.

510(k) K212375

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 NumberK212375 Date4 Jan 2022ClearedStatusActive

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  • Withdrawn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, 26 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 Surgical Mask is a medical device designed to provide a physical barrier for the wearer. It is intended to be used in general hospital settings to help prevent the transmission of microorganisms and particulate matter.

This device is supplied by Jiangxi Bestgrand Health Technology Co., Ltd. and has received FDA 510(k) clearance under K212375. It is classified as a Class 2 device under product code FXX.

Questions

AI-generated answers, 26 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 physical barrier for the wearer. It is intended for use in general hospital settings to assist in preventing the transmission of particulate matter and microorganisms between the wearer and the environment.

  • Is this device cleared for medical use?

    Yes, this mask has received FDA 510(k) clearance under K212375. It is classified as a Class 2 medical device under product code FXX, indicating it has been found substantially equivalent to legally marketed predicate devices.

  • Who is the manufacturer of this mask?

    This medical device is manufactured by Jiangxi Bestgrand Health Technology Co., Ltd., located in the Bestgrand Industrial Park in Pingxiang, China.