Innonix Antiviral Child's Face Mask
FDA 510(k) clearance K192105 · decided 2019-11-29
Clearance details
- K-number
- K192105
- Device name
- Innonix Antiviral Child's Face Mask
- Applicant
- Innonix Technologies Limited
- Decision
- Substantially Equivalent
- Date received
- 2019-08-05
- Decision date
- 2019-11-29
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- OUK
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Siu Lek Yuen,Shatin, HK
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ProGear® Surgical Mask with Oxafence®, Model AV82030 (K231741) | Prestige Ameritech | 2024-09-05 |
| Cufitec Surgical Mask (K182766) | Nbc Meshtec, Inc. | 2019-01-03 |
| BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013 (K101128) | Filligent Limited | 2011-05-26 |
Recalls involving this device
No recalls on record reference this clearance.