510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K231741Substantially Equivalent

ProGear® Surgical Mask with Oxafence®, Model AV82030

Prestige Ameritech, North Richland Hills TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K231741 is the FDA 510(k) clearance record for ProGear® Surgical Mask with Oxafence®, Model AV82030, a class II device, cleared for Prestige Ameritech on under FDA product code OUK (Surgical Mask With Antimicrobial/Antiviral Agent). FDA's definition for product code OUK reads: "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...". FDA records list 6 510(k) clearances for Prestige Ameritech, from to . As of , FDA records show no recalls naming K231741.

Clearance record

Decision date
Received
(449 days to decision)
Product code
OUK Surgical Mask With Antimicrobial/Antiviral Agent
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Prestige Ameritech 7201 Iron Horse Blvd., North Richland Hills TX
510(k) summary
Statement
Third party review
No

Clearances, product code OUK

Trailing 12 months

FDA records hold no clearances under product code OUK in the trailing twelve months.

FDA records show no clearances under product code OUK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OUK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260