510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K101128Substantially Equivalent

Biofriend Biomask Surgical Facemask, Models Universal Bf-200-2001 and Premium Bf-200-3013

Filligent Limited, Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101128 is the FDA 510(k) clearance record for BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013, a class II device, cleared for Filligent Limited 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 2 510(k) clearances for Filligent Limited, from to . As of , FDA records show no recalls naming K101128.

Clearance record

Decision date
Received
(399 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
Filligent Limited 611 W. 5th St. Third Floor, Austin TX
510(k) summary
Summary PDF
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