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Disposable Surgical Mask (FXX)

by Heilongjiang Yinjia Medical Equipment Co., Ltd.

510(k) K212944

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 NumberK212944 Date15 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  • Withdrawn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)

Full name
Disposable Surgical Mask
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, 19 Sep 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 Disposable Surgical Mask, classified under 21 CFR 878.4040 as a single-use barrier protection for healthcare personnel and patients during surgical procedures. It is designed to reduce the risk of airborne and droplet transmission of pathogens by filtering exhaled air and blocking large-particle splashes, ensuring sterile field integrity during operations.

The mask is intended for single-use in sterile surgical environments and must be discarded after one procedure. Supplied in sterile packaging, it adheres to FDA 510(k) clearance (K212944) under the General, Plastic Surgery (SU) Subpart E category. No additional regulatory markings (e.g., MRI safety, reusable status) are indicated in the specifications.

Questions

AI-generated answers, 19 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 primary purpose of this disposable surgical mask in a clinical setting?

    This disposable surgical mask is designed to create a barrier between healthcare personnel and patients during surgical procedures, reducing the risk of airborne and droplet transmission of pathogens. It filters exhaled air and blocks large-particle splashes, helping maintain a sterile field to protect both the patient and the surgical team.

  • Is this mask intended for reuse, or is it meant to be used only once?

    The mask is explicitly labeled for single-use only and must be discarded after one surgical procedure. This ensures optimal performance and sterility, as reuse could compromise its protective integrity and increase infection risks.

  • How is this mask supplied, and what does the sterile packaging ensure?

    The mask comes in sterile packaging, which guarantees it is free from contaminants before use. This packaging is critical for maintaining sterility in surgical environments, ensuring the mask meets its intended purpose of protecting against airborne and droplet-borne pathogens during procedures.

  • What regulatory pathway was followed for FDA clearance of this device?

    This mask received FDA 510(k) clearance (K212944) under the General, Plastic Surgery (SU) Subpart E category, following a traditional 510(k) review process. The device was determined to be substantially equivalent to a legally marketed predicate, meaning it meets the same performance and safety standards as existing surgical masks.

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

    The provided specifications do not detail specific sizes or models for this mask, so availability would need to be confirmed directly with the manufacturer, Heilongjiang Yinjia Medical Equipment Co., Ltd. However, standard disposable surgical masks typically come in one or two sizes (e.g., adult or pediatric) to accommodate different user needs.