K192105 is an FDA 510(k) clearance for the Innonix Antiviral Child's Face Mask. This device is classified as 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 FDA review panel. Regulated under 21 CFR 878.4040. 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..
| 510(k) Number | K192105 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| 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. |