← Back to catalogue

Procedure Mask/Surgical Mask/Face Mask

FDA 510(k)

Class II (US FDA 510(k))

510(k) K223232

by Winner Medical Co., Ltd.

Identifiers

510(k) Number
K223232 FDA 510(k)
FDA Product Code
FXX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4040 FDA 510(k)
Regulation Number
878.4040 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Procedure Mask/Surgical Mask/Face Mask, classified under 21 CFR 878.4040 as a barrier device designed to protect both patients and healthcare personnel from airborne microorganisms, body fluids, and particulate matter during medical procedures. It is intended for single-use in clinical settings to minimize cross-contamination risks during surgical or procedural interventions.

The mask is supplied sterile and intended for single-use only, adhering to FDA 510(k) clearance (K223232) under the Traditional 510(k) Review pathway. It is manufactured by Winner Medical Co., Ltd. in Shenzhen, China, and must be stored in a clean, dry environment to maintain sterility. No MRI safety or reusable variants are specified in the regulatory submission.

Frequently asked questions

What types of medical procedures is this mask designed to protect against contamination during?

This mask is designed as a barrier device to protect both patients and healthcare personnel from airborne microorganisms, body fluids, and particulate matter during surgical or procedural interventions. It is intended for use in clinical settings where minimizing cross-contamination risks is critical, such as surgeries or medical procedures where exposure to contaminants could compromise safety.

Is this mask reusable, or is it meant for single-use only? How does that affect its use?

This mask is explicitly intended for single-use only to minimize cross-contamination risks. Its sterile packaging ensures it remains uncontaminated until first use, and reuse is not supported by the manufacturer or regulatory submission. This design reduces infection risks and aligns with best practices for barrier devices in clinical settings.

How should I store this mask to maintain its sterility and effectiveness?

The mask must be stored in a clean, dry environment to preserve sterility. Avoid exposure to moisture, direct sunlight, or extreme temperatures, as these can compromise its integrity. The manufacturer’s packaging should remain intact until immediate use to ensure it remains sterile and functional as intended.

What regulatory pathway was used for FDA clearance, and what does that mean for its safety and equivalence?

This mask received FDA clearance through the Traditional 510(k) Review pathway under clearance number K223232, with a decision of Substantially Equivalent (SESE). This means the FDA determined it is as safe and effective as a legally marketed predicate device, ensuring it meets established standards for barrier protection in clinical settings. The review was conducted by the Orthopaedics and Rehabilitation Devices Advisory Panel (SU).

Are there different sizes or models available for this mask? If so, how would I identify them?

The provided data does not specify multiple sizes or models for this mask. The regulatory submission lists it generically as a Procedure Mask/Surgical Mask/Face Mask under product code FXX, so no additional variants (e.g., sizes, colors, or specialized designs) are mentioned. Always verify the specific model or size requirements with the manufacturer or purchasing documentation.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Protective Face Masks Manufacturer China | Winner Medical, Medical Masks Manufacturer China | Winner Medical, Procedure mask/Surgical mask/Face mask (K250082) — FDA 510 (k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Winner Medical Co., Ltd.

Sources (1)

  • FDA 510(k) K223232 24 fields · synced Sep 19, 2026