← Back to catalogue

Procedure Mask/Surgical Mask/Face Mask

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K220194

by Winner Medical Co., Ltd.

Identifiers

510(k) Number
K220194 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 surgical apparel. It is designed to provide a barrier against transfer of microorganisms, body fluids, and particulate matter, ensuring protection for both patients and healthcare personnel during medical procedures.

The mask is supplied as a single-use, non-sterile item and is intended for use in clinical settings such as operating rooms, examination rooms, and other healthcare environments. It adheres to FDA 510(k) clearance (K250082) and MDR compliance, with regulatory approvals granted under the Traditional 510(k) pathway. No MRI safety or reusable specifications are indicated.

Frequently asked questions

Is this mask intended for reuse in clinical settings, or is it meant for single-use only?

This mask is explicitly supplied as a single-use item, meaning it should not be reused after one application. The manufacturer’s description and regulatory classification under 21 CFR 878.4040 (surgical apparel) confirm it is designed for one-time use to maintain barrier integrity and hygiene standards in healthcare environments like operating rooms or examination rooms.

What types of environments or procedures is this mask suitable for, and why?

This mask is designed for clinical settings such as operating rooms, examination rooms, and other healthcare environments where protection against microorganisms, body fluids, and particulate matter is required. Its classification as surgical apparel under 21 CFR 878.4040 and its FDA 510(k) clearance (K220194) indicate it meets standards for procedures where contamination control is critical, such as surgeries or patient examinations.

How should I store this mask to ensure it remains effective when needed?

Since this is a non-sterile single-use mask, storage should protect it from contamination and physical damage. Keep it in its original packaging until use, away from direct sunlight, moisture, or extreme temperatures. The lack of sterility specifications means it doesn’t require sterile storage conditions, but maintaining cleanliness and integrity of the packaging is essential to preserve its barrier properties.

Are there different sizes or models available for this mask, and if so, how do I identify them?

The provided data does not specify sizes or distinct models for this mask, as the description and specifications focus on its general design and regulatory compliance. If multiple sizes exist, they would likely be indicated on the packaging or product labeling (e.g., small, medium, large). For now, this mask appears to be offered as a standard procedure/surgical mask without size differentiation in the available documentation.

What regulatory pathways does this mask follow, and how does that affect its use in healthcare?

This mask follows FDA 510(k) clearance (K220194) under the Traditional 510(k) pathway, meaning it was determined to be substantially equivalent to a legally marketed predicate device. It also complies with MDR (Medical Device Regulation) standards, ensuring it meets both U.S. and EU requirements for safety and performance. These approvals confirm its suitability for use in clinical settings where barrier protection against fluids and microorganisms is required, as outlined in its classification under 21 CFR 878.4040.

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, Procedure mask/Surgical mask/Face mask (K250082) — FDA 510 (k) | Innolitics, K250082 - Procedure mask/Surgical mask/Face mask | FDA 510(k)

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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

Manufacturer

Manufacturer
Winner Medical Co., Ltd.

Sources (2)

  • FDA 510(k) K220194 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 29, 2026