Cleared Traditional

Innonix Antiviral Child's Face Mask

K192105 · Innonix Technologies Limited · General Hospital
Nov 2019
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K192105 is an FDA 510(k) clearance for the Innonix Antiviral Child's Face Mask, a Surgical Mask With Antimicrobial/antiviral Agent (Class II — Special Controls, product code OUK), submitted by Innonix Technologies Limited (Siu Lek Yuen,Shatin, HK). The FDA issued a Cleared decision on November 29, 2019, 116 days after receiving the submission on August 5, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K192105 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 2019
Decision Date November 29, 2019
Days to Decision 116 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code OUK — Surgical Mask With Antimicrobial/antiviral Agent
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4040
Definition 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.