K212926 is an FDA 510(k) clearance for the AllureTM Surgical Mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Allure Gift Wraps Private Limited (Vapi, IN). The FDA issued a Cleared decision on September 16, 2022, 367 days after receiving the submission on September 14, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K212926 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 2021 |
| Decision Date | September 16, 2022 |
| Days to Decision | 367 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FXX - Mask, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |