510(k) K192105
K192105 is an FDA 510(k) premarket notification submitted by Innonix Technologies Limited for the device "Innonix Antiviral Child's Face Mask". The FDA issued a decision of Substantially Equivalent on November 29, 2019. The device falls under product code OUK (Surgical Mask With Antimicrobial/Antiviral Agent), a Class II device regulated under 21 CFR 878.4040.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 29, 2019
- Date Received
- August 5, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Surgical Mask With Antimicrobial/Antiviral Agent
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type
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.