Product code OUK

Device name

Surgical Mask With Antimicrobial/Antiviral Agent

Medical specialty

General, Plastic Surgery

Device class

2

Regulation number

878.4040

Review panel

HO

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset