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Kangbeier Child Surgical Mask

by Xinxiang Kangbeier Medical Technology Co., Ltd.

510(k) K221753

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 NumberK221753 Date21 Dec 2023ClearedStatusActive

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  • Withdrawn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
OXZ
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 Kangbeier Child Surgical Mask is a pediatric facemask designed for use as surgical apparel. It functions as a protective barrier to cover the nose and mouth.

This device is classified as a Class II medical device under regulation number 878.4040. It has received FDA 510(k) clearance through the traditional pathway.

Other devices from Xinxiang Kangbeier Medical Technology Co., Ltd.

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 the Kangbeier Child Surgical Mask?

    This device is designed specifically for pediatric use as surgical apparel. It functions as a protective barrier intended to cover the nose and mouth of a child during surgical procedures.

  • What is the regulatory status of this mask?

    The Kangbeier Child Surgical Mask is classified as a Class II medical device under regulation number 878.4040. It has received FDA 510(k) clearance through the traditional pathway under K-number K221753.

  • Who is the manufacturer of this pediatric mask?

    The device is manufactured by Xinxiang Kangbeier Medical Technology Co., Ltd., located in the East Mancun Industrial District of Changyuan, China.