Product code OUK— General, Plastic Surgery

“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.”

FDA has cleared 4 devices under product code OUK between 2011 and 2024, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20241 clearance
• 20192 clearances
• 20111 clearance

• Prestige Ameritech1 clearance
• Nbc Meshtec, Inc.1 clearance
• Innonix Technologies Limited1 clearance
• Filligent Limited1 clearance

• K231741 — ProGear® Surgical Mask with Oxafence®, Model AV82030Prestige Ameritech·2024-09-05
• K192105 — Innonix Antiviral Child's Face MaskInnonix Technologies Limited·2019-11-29
• K182766 — Cufitec Surgical MaskNbc Meshtec, Inc.·2019-01-03
• K101128 — BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013Filligent Limited·2011-05-26