The following data is part of a premarket notification filed by Allure Gift Wraps Private Limited with the FDA for Alluretm Surgical Mask.
| Device ID | K212926 |
| 510k Number | K212926 |
| Device Name: | AllureTM Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Allure Gift Wraps Private Limited Plot No. J-21, J Type Area, 1st Phase, GIDC Vapi, IN 396195 |
| Contact | Mohan Jairam Raisinghani |
| Correspondent | Sharad Raisinghani Allure Life Sciences LLC 4Hancock CT, Basking Ridge, New Jersey, NJ 07920 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-14 |
| Decision Date | 2022-09-16 |