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Medical Face Mask M001

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K221273

by Xingyu Medical Tech Co., Ltd

Identifiers

510(k) Number
K221273 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)

The Medical Face Mask M001 is a Mask, Surgical device, designed to provide a barrier against airborne contaminants, splashes, and sprays. It is classified under product code FXX and intended for single-use in clinical settings to reduce the risk of infection transmission during medical procedures.

This device is supplied as a sterile, disposable item and is regulated under FDA 510(k) clearance (K221273) and the EU Medical Device Regulation (MDR). It is intended for use in general and plastic surgery settings, adhering to standards for Class 2 medical devices. No MRI safety or reusable specifications are indicated.

Frequently asked questions

Is this face mask designed for reuse in clinical settings, or is it meant to be used only once?

The Medical Face Mask (M001) is explicitly designed for single-use in clinical settings. The product description and specifications confirm it is a sterile, disposable item, intended to reduce infection transmission during procedures without being reused.

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

This mask is intended to provide a barrier against airborne contaminants, splashes, and sprays, which helps reduce the risk of infection transmission during medical procedures. While the advisory committee category (General, Plastic Surgery) suggests it’s commonly used in those settings, its primary function is universal protection against fluid and particle exposure—not procedure-specific.

How should I store this mask before use, and does it require special handling?

Since the mask is sterile and disposable, it should be stored in its original, sealed packaging to maintain sterility until use. Avoid exposure to moisture, extreme temperatures, or contamination. The lack of reusable specifications means no cleaning or reprocessing is intended, so discard any unused masks per facility protocols.

Are there different sizes or models available for this face mask?

The provided data does not specify multiple sizes or models for the Medical Face Mask (M001). It is described as a single product variant under product code FXX, intended for general surgical use. If size variations exist, they are not detailed in the available information.

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

The mask is regulated under FDA 510(k) clearance (K221273) and the EU Medical Device Regulation (MDR), confirming it meets Class 2 standards for surgical masks. This means it has undergone premarket review for safety and performance, ensuring compliance with both U.S. and EU requirements. Clinicians should verify local compliance before use, but the regulatory status indicates it’s approved for single-use in clinical settings as described.

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: K221273 - Medical Face Mask (M001) | FDA 510 (k), Medical Face Mask (M001) 510 (k) K221273 - FDA.report, Medical Face Mask (M001) — FDA 510 (k) K221273 | MedTracker, Medical Face Mask (M001) (K221273) — FDA 510(k) | Innolitics

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Xingyu Medical Tech Co., Ltd
FDA Applicant
Xingyu Medical Tech Co., Ltd.

Sources (2)

  • FDA 510(k) K221273 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026