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Procedure Mask/Surgical Mask/Face Mask

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K250082

by Winner Medical Co., Ltd.

Identifiers

510(k) Number
K250082 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 the FXX product code. It is designed to provide a barrier against airborne contaminants, splashes, sprays, and large-particle droplets, ensuring protection for both patients and healthcare providers during medical procedures. Its construction adheres to standards for surgical environments, where infection control is critical.

The mask is supplied as a single-use, non-sterile item, intended for use in clinical settings such as operating rooms, examination rooms, and other medical procedures. It is regulated under FDA 510K and MDR authorisations, with a clearance decision dated 2025-06-18 for substantial equivalence in the General, Plastic Surgery advisory committee category. Sizes and packaging details are not specified in the provided data.

Frequently asked questions

What types of medical environments is this mask intended for and why?

This mask is designed for use in clinical settings such as operating rooms, examination rooms, and other medical procedures where infection control is critical. It provides a barrier against airborne contaminants, splashes, sprays, and large-particle droplets, ensuring protection for both patients and healthcare providers during procedures. Its construction adheres to standards for surgical environments, making it suitable for high-risk areas where minimizing infection transmission is essential.

Is this mask reusable or single-use, and what does that mean for its use in a hospital?

This mask is explicitly labeled as a single-use item, meaning it is intended for one-time use only and should not be reused. In a hospital setting, this ensures hygiene and reduces the risk of cross-contamination between patients or healthcare workers. After use, it must be discarded properly according to infection control protocols.

How is this mask regulated, and what does that tell me about its safety standards?

The mask is regulated under FDA 510K and MDR (Medical Device Regulation) authorizations, with a clearance decision dated 2025-06-18 for substantial equivalence in the General, Plastic Surgery advisory committee category. This means it has undergone review by regulatory bodies to ensure it meets established safety and performance standards for surgical masks, providing assurance of its reliability in clinical settings.

Is this mask sterile, and if not, what precautions should I take when handling it?

The mask is non-sterile, meaning it is not intended for use in sterile procedures (e.g., open surgery) without additional sterilization. When handling it, follow standard infection control practices—such as washing hands before and after use—to minimize contamination risk. If used in a sterile field, it should be treated as a non-sterile item and not relied upon for sterility.

What should I know about storage before using this mask in a medical facility?

While specific storage instructions aren’t detailed in the data, as a non-sterile, single-use item, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Ensure packaging remains intact until use to prevent contamination. If stored in bulk, check expiration dates (if applicable) and avoid exposure to moisture or chemicals that could compromise its integrity.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Winner Medical Co., Ltd.

Sources (2)

  • FDA 510(k) K250082 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026