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Single-Use Medical Face Mask

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K201974

by Guangdong Horigen Mother & Baby Products Co., Ltd.

Identifiers

510(k) Number
K201974 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 single-use medical face mask, classified under the nomenclature for respiratory protective devices. It is designed to provide barrier protection against airborne particles, droplets, and splashes, helping to reduce the risk of infection transmission in clinical and healthcare settings.

The mask is intended for single-use only and is supplied sterile. It is regulated under the FDA’s 510(k) clearance process, with a decision dated March 7, 2021, confirming substantial equivalence to predicate devices. Compliance with MDR (Medical Device Regulation) standards is also noted. Sizes and specific model variations are not detailed in the provided data.

Frequently asked questions

Is this mask reusable or designed for single-use only, and how does that affect its use in clinical settings?

This mask is explicitly designed for single-use only, meaning it should not be reused after one application. This design choice ensures optimal barrier protection against airborne particles, droplets, and splashes, reducing the risk of cross-contamination in healthcare settings. Single-use masks are also supplied sterile, which eliminates the need for cleaning or reprocessing between uses, simplifying infection control protocols.

What regulatory pathways does this mask follow, and what does that mean for its use in healthcare facilities?

This mask has undergone FDA 510(k) clearance (decision dated March 7, 2021) and complies with MDR (Medical Device Regulation) standards. The FDA’s 510(k) process confirms it is substantially equivalent to predicate devices, ensuring it meets established safety and performance criteria for respiratory protective devices. Compliance with MDR further validates its adherence to European Union safety and quality requirements, making it suitable for use in regulated healthcare environments where such approvals are recognized.

How is this mask supplied, and what does the sterility guarantee mean for its handling?

The mask is supplied sterile, meaning it undergoes processing to eliminate or reduce viable microorganisms to ensure safety for direct use on patients or healthcare providers. This eliminates the need for additional sterilization steps by the end-user, reducing the risk of contamination during handling. However, since it is single-use, it must remain unopened until first use and discarded immediately after to maintain sterility and effectiveness.

Are there different sizes or models available for this mask, and if not, how does that impact its versatility?

The provided data does not specify sizes or model variations for this mask, which may limit its versatility for users with diverse facial anatomies or specific fit requirements. In clinical settings, a one-size-fits-all design may necessitate additional adjustments (e.g., ear loops, ties) to achieve a proper seal. Buyers should verify fit compatibility with their target population or consult the manufacturer for additional sizing options if needed.

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
Guangdong Horigen Mother & Baby Products Co., Ltd.

Sources (2)

  • FDA 510(k) K201974 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026