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Surgical Mask

by Jiangsu Xingtong Biotechnology Group Co., Ltd.

510(k) K211454

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 NumberK211454 Date18 Aug 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  • Withdrawn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.

The surgical mask is a medical device classified under product code FXX. It is designed to function as a mask for surgical use.

This device received FDA 510(k) clearance on August 18, 2021, under the reference number K211454. It is manufactured by Jiangsu Xingtong Biotechnology Group Co., Ltd. and is categorized as a Class II medical device.

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 intended use of this surgical mask?

    This device is designed specifically for surgical use. It is classified under product code FXX and serves as a protective barrier during medical procedures.

  • What is the regulatory status of this device?

    This surgical mask received FDA 510(k) clearance on August 18, 2021, under reference number K211454. It is categorized as a Class II medical device.

  • Who is the manufacturer of this surgical mask?

    The device is manufactured by Jiangsu Xingtong Biotechnology Group Co., Ltd., located in the Beizhou Industrial Park in Yangzhou, China.