Surgical Mask With Antimicrobial/Antiviral Agent

OUK · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4040

Classification

FDA Product Code: OUK
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 878.4040
Review panel: HO
Medical specialty: General, Plastic Surgery
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 4
Registered establishments: 3

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown