Skip to content

Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A)

by Jiangmen Ningrui Medical Supplies Co., Ltd.

510(k) K212293

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 NumberK212293 Date25 Oct 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  • Withdrawn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, 1 Oct 2026

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

This device is a surgical mask, a type of face covering designed to provide a physical barrier against fluids and particulate matter during medical procedures. It is intended for use in healthcare settings to help reduce the risk of exposure to blood and bodily fluids for both the wearer and others in the vicinity.

The surgical mask is supplied non-sterile and is designed for single-use only. It is available in multiple models (WK1701-02A, WK1701-03A, WK1701-04A) and has received FDA 510(k) clearance (K212293) as a Class II device, with a determination of substantial equivalence to a legally marketed predicate device.

Questions

AI-generated answers, 1 Oct 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 surgical mask used for?

    The surgical mask is designed to provide a physical barrier against fluids and particulate matter during medical procedures. It helps reduce the risk of exposure to blood and bodily fluids for both the wearer and others in healthcare settings.

  • Is the surgical mask sterile or non-sterile, and can it be reused?

    The surgical mask is supplied non-sterile and is designed for single-use only. It should not be reused, as reuse may compromise its barrier effectiveness and increase contamination risk.

  • What models are available for this surgical mask?

    The surgical mask is available in three models: WK1701-02A, WK1701-03A, and WK1701-04A. These model numbers distinguish the specific variants offered by the manufacturer.