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Surgical Face Mask (Ear Loops and Tie-On)

by Wuhan DYMEX Healthcare Co., Ltd

510(k) K210433

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 NumberK210433 Date7 Jun 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  • Withdrawn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
FDA applicant
Wuhan Dymex Healthcare Co., Ltd.
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 Face Mask, classified under the FDA product code FXX, designed to provide barrier protection for healthcare personnel and patients during surgical and medical procedures. It features ear loops and a tie-on design to ensure secure fit and ease of use, with a stable nose clip to enhance sealing around the nose. The mask is intended for single-use in controlled clinical environments where infection control is critical.

The Surgical Face Mask (Ear Loops and Tie-On) is supplied as a sterile, single-use device and is regulated under FDA 510(k) clearance (K210433) as substantially equivalent to predicate devices. It is intended for use in general and plastic surgery settings, adhering to FDA classification under 878.4040. No reusable or MRI-compatible specifications are noted, and storage conditions are not detailed in the regulatory submission.

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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 Face Mask (Ear Loops & Tie-On) designed for?

    This mask is intended to provide barrier protection for healthcare personnel and patients during surgical and medical procedures, particularly in general and plastic surgery settings. Its ear loops and tie-on design ensure a secure fit, while the stable nose clip improves sealing around the nose to reduce contamination risks.

  • Is this mask reusable or single-use?

    The Surgical Face Mask (Ear Loops & Tie-On) is explicitly designed for single-use only. This aligns with infection control best practices in clinical environments, where disposable masks minimize cross-contamination risks between patients and healthcare providers.

  • How is the mask supplied, and is it sterile?

    The mask is supplied as a sterile, single-use device. Sterility is critical for surgical settings to prevent microbial transmission, and the packaging ensures this standard is maintained until first use.

  • What regulatory clearance does this mask hold?

    The mask holds FDA 510(k) clearance (K210433) under the product code FXX, classified under 878.4040. It is deemed substantially equivalent to predicate devices, meaning it meets the same performance and safety standards as existing approved masks in its category.

  • Are there different sizes or models available for this mask?

    The provided data does not specify multiple sizes or models for this mask. However, the ear loops and tie-on design suggest it is intended for general adult use, with the nose clip adjustable to accommodate varying facial contours. For precise fit requirements, consult manufacturer documentation.