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Topwide Surgical Face Mask

by Topwide (Hubei) Medical Products Manufacturer

510(k) K210102

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 NumberK210102 Date17 Dec 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  • Withdrawn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, 25 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 Topwide Surgical Face Mask is a disposable medical device designed to provide a barrier against contaminants and fluids. It is intended for use in surgical and healthcare settings to protect both the wearer and the patient from airborne particles and splashes.

The mask is supplied sterile and is intended for single-use. It is not MRI safe and is available in standard sizes. The device is regulated under FDA 510(k) clearance and is manufactured by Topwide (Hubei) Medical Products Manufacturer.

Questions

AI-generated answers, 25 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 Topwide Surgical Face Mask used for?

    The Topwide Surgical Face Mask is a disposable medical device designed to provide a barrier against contaminants and fluids. It is intended for use in surgical and healthcare settings to protect both the wearer and the patient from airborne particles and splashes.

  • Is the Topwide Surgical Face Mask sterile?

    Yes, the Topwide Surgical Face Mask is supplied sterile and is intended for single-use. This ensures that the device is free from microorganisms and ready for immediate use in a clinical environment.

  • Is the Topwide Surgical Face Mask MRI safe?

    No, the Topwide Surgical Face Mask is not MRI safe. It is a disposable medical device made of materials that are not compatible with magnetic resonance imaging environments.

  • What are the specifications and regulatory status of the Topwide Surgical Face Mask?

    The Topwide Surgical Face Mask is available in standard sizes and is regulated under FDA 510(k) clearance. It was cleared on December 17, 2021, with a decision of Substantially Equivalent.