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
K122702Substantially Equivalent

Biofriend Biomask N95 Surgical Respirator

Filligent Limited, Hong Kong, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K122702 is the FDA 510(k) clearance record for BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR, a class II device, cleared for Filligent Limited on under FDA product code ONT (N95 Respirator With Antimicrobial/Antiviral Agent). FDA's definition for product code ONT reads: "A single use, disposable, NIOSH-approved respirator intended for occupational use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological particulates and has an added antimicrobial and/or...". FDA records list 2 510(k) clearances for Filligent Limited, from to . As of , FDA records show no recalls naming K122702.

Clearance record

Decision date
Received
(195 days to decision)
Product code
ONT N95 Respirator With Antimicrobial/Antiviral Agent
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Filligent Limited 7th Fllor, 69 Jervois St.,, Hong Kong, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ONT

Trailing 12 months

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

FDA records show no clearances under product code ONT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ONT, 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