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
K192105Substantially Equivalent

Innonix Antiviral Child's Face Mask

Innonix Technologies Limited, Siu Lek Yuen,Shatin, HK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192105 is the FDA 510(k) clearance record for Innonix Antiviral Child's Face Mask, a class II device, cleared for Innonix Technologies 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 one 510(k) clearance for Innonix Technologies Limited. As of , FDA records show no recalls naming K192105.

Clearance record

Decision date
Received
(116 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
Innonix Technologies Limited 13/F Lifung Centre, 2 On Ping St., Siu Lek Yuen,Shatin, HK
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