OUK

Surgical Mask With Antimicrobial/Antiviral Agent

Product code

OUK

Device name

Surgical Mask With Antimicrobial/Antiviral Agent

Device class

Class 2

21 CFR

21 CFR 878.4040

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

510(k) clearances (last 3 years)

4

FDA classification definition

A single use, disposable surgical mask for occupational use to cover the nose and mouth of the wearer to protect from the transfer of microorganisms,body fluids and particulates and has an added antimicrobial and/or antiviral agent which kills specific pathogens under specified contact conditions.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-09-05.