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Disposable Surgical Face Mask (M01, M02)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K220512

by Fomed Industries Inc

Identifiers

510(k) Number
K220512 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 Disposable Surgical Face Mask, classified as a barrier device designed to protect the wearer’s respiratory tract from contamination by airborne particles, droplets, and splashes during surgical and medical procedures. It is intended for single-use in clinical settings where sterile protection is required, such as operating rooms, dental clinics, and other healthcare environments.

The mask is supplied sterile, intended for one-time use only, and must be discarded after use to maintain infection control standards. It is regulated under FDA 510(k) clearance (K220512) and EU MDR compliance, with no specific MRI safety considerations. Available in two variants (M01, M02), it is packaged individually for immediate clinical use and adheres to standard surgical mask performance criteria for fluid resistance and filtration efficiency.

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
Fomed Industries Inc
FDA Applicant
Fomed Industries, Inc.

Sources (2)

  • FDA 510(k) K220512 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026