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Surgical Face Mask

by Xiantao Deming Healthcare Products Co., Ltd.

510(k) K212574

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 NumberK212574 Date14 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  • Withdrawn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, 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 product code FXX. It is designed to provide a barrier against respiratory secretions, splashes, and large-particle aerosols, ensuring protection for both patients and healthcare providers during surgical and medical procedures. Constructed from non-woven materials, it adheres to standards for fluid resistance and filtration efficiency to minimize contamination risks in controlled clinical environments.

The mask is intended for single-use in operating rooms, clinical settings, and other sterile environments where airborne contamination must be mitigated. Supplied in sterile packaging, it complies with FDA 510(k) clearance under the Traditional pathway, classified as Substantially Equivalent to predicate devices. No reusable or MRI-compatible variants are indicated; sizes are standardized for adult use. Storage requires protection from moisture and direct sunlight to preserve sterility and integrity.

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 primary purpose of this surgical face mask?

    This surgical face mask is designed to create a barrier against respiratory secretions, splashes, and large-particle aerosols, reducing contamination risks during surgical and medical procedures. Its fluid-resistant, non-woven material ensures protection for both patients and healthcare providers in sterile environments like operating rooms.

  • Is this mask intended for reuse or single-use?

    The mask is explicitly designed for single-use only. This ensures optimal hygiene and sterility, as reuse could compromise its protective integrity and increase infection risks in clinical settings.

  • What sizes are available for this surgical face mask?

    This mask is standardized for adult use, meaning it is manufactured to fit the average adult face without additional sizing options. The design adheres to industry norms for adult surgical masks, ensuring a secure seal and effective protection.

  • How should this mask be stored to maintain sterility?

    To preserve sterility and structural integrity, store the mask in its original packaging, away from moisture and direct sunlight. Exposure to these elements can degrade the material or compromise the sterile barrier, reducing its effectiveness in clinical environments.

  • Does this mask require any special handling or preparation before use?

    No special handling is required beyond removing the mask from its sterile packaging immediately before use. The mask is pre-sterilized and ready for application, ensuring no additional preparation steps are needed in fast-paced clinical settings.