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MEO Med Disposable Medical Face Mask

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K210870

by Fujian Meo Medical Technology Limited

Identifiers

510(k) Number
K210870 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 MEO Med Disposable Medical Face Mask is a surgical mask (product code FXX) designed to protect both patients and healthcare personnel from exposure to microorganisms, body fluids, and particulate matter. Classified as a Class II device under special controls, it adheres to regulatory standards for infection control in clinical settings.

This single-use, disposable mask is intended for use in healthcare environments where barrier protection is required. Supplied sterile, it complies with FDA 510(k) clearance (K210870) and EU MDR authorisation. Storage should follow manufacturer guidelines to maintain sterility and integrity until use.

Frequently asked questions

What types of environments is this mask designed for and why is it considered single-use?

This mask is specifically designed for healthcare environments where protecting both patients and healthcare personnel from microorganisms, body fluids, and particulate matter is critical. It is classified as a single-use device because repeated use could compromise its barrier properties, sterility, or structural integrity, potentially increasing the risk of contamination or reduced effectiveness. The manufacturer emphasizes maintaining sterility until use, which aligns with single-use guidelines to ensure optimal infection control.

How should I store this mask to ensure it remains effective and sterile until use?

The mask should be stored following the manufacturer’s guidelines to preserve sterility and structural integrity. Since it is supplied sterile, avoid exposure to moisture, direct sunlight, or extreme temperatures, which could compromise its protective qualities. Store it in a clean, dry environment, and use it immediately after opening the packaging to prevent contamination.

Are there different sizes or models available for this mask, and if so, how do I know which one to choose?

The provided specifications do not list specific size variations (e.g., small, medium, large) for the MEO Med Disposable Medical Face Mask. Since it is a standard surgical mask (product code FXX), it is likely designed to fit most adult faces. If sizing is a concern, refer to the manufacturer’s packaging or instructions for fit guidance, as improper fit can reduce effectiveness. If specialized sizing is required, additional models may be available under a different product line.

What regulatory pathways has this mask undergone, and what does that mean for its safety and compliance?

This mask has undergone FDA 510(k) clearance (K210870) and EU MDR authorization, meaning it has been evaluated against regulatory standards for safety, performance, and compliance with infection control requirements. The FDA 510(k) designation indicates it is deemed substantially equivalent to a predicate device, while EU MDR compliance ensures adherence to European Union medical device regulations. Both pathways confirm that the mask meets established criteria for use in clinical settings.

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: MEO Med Disposable Medical Face Mask by Fujian MEO Medical Technology ..., MEO Med Disposable Medical Face Mask (K210870) - FDA 510(k), Meo Med Disposable Face Mask, Fashionable Face Mask ... - Amazon

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Fujian Meo Medical Technology Limited

Sources (2)

  • FDA 510(k) K210870 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026