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Surgical Face Mask

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K212575

by Hubei Huanfu Plastic Products Co., Ltd

Identifiers

510(k) Number
K212575 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 Surgical Face Mask is a disposable barrier device designed to protect the wearer’s mouth and nose from contamination by respiratory secretions, splashes, sprays, or airborne pathogens. Classified under the nomenclature for protective face masks, it is intended for single-use in surgical and medical settings to maintain sterile field integrity and reduce infection risk during procedures.

Supplied in sterile packaging, the mask is intended for one-time use and must be discarded after use. It complies with FDA 510(k) clearance under the Traditional pathway (K212575) and meets EU MDR requirements, with no third-party certification noted. Sizes and materials are not specified in the data, but it is categorized under product code FXX for general surgical use.

Frequently asked questions

What is the primary purpose of this Surgical Face Mask in medical settings?

This Surgical Face Mask is designed as a disposable barrier device to protect the wearer’s mouth and nose from contamination by respiratory secretions, splashes, sprays, or airborne pathogens. It helps maintain sterile field integrity during surgical and medical procedures, thereby reducing the risk of infection for both the patient and healthcare provider.

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

The mask is explicitly intended for single-use only and must be discarded after use. The packaging is sterile, and reuse could compromise its protective properties and increase infection risks.

How is this mask supplied, and what does that mean for handling?

The mask is supplied in sterile packaging, meaning it is pre-sterilized and ready for immediate use without additional processing. This ensures contamination-free use during procedures, but the packaging must remain intact until use.

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

The mask is cleared under the FDA 510(k) Traditional pathway (K212575) and complies with EU MDR requirements, though no third-party certification is noted. This means it meets U.S. and EU standards for safety and performance as a surgical barrier device, but clinicians should confirm local compliance rules before use.

Are there different sizes or models available for this mask, or is it a one-size-fits-all design?

The provided data does not specify sizes or models, so it appears this mask is categorized under a general product code (FXX) for surgical use. Buyers should confirm with the manufacturer if specific sizing or fit requirements are needed for their clinical applications.

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
Hubei Huanfu Plastic Products Co., Ltd
FDA Applicant
Hubei Huanfu Plastic Products Co., Ltd.

Sources (2)

  • FDA 510(k) K212575 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026