The following data is part of a premarket notification filed by Hubei Medlink Healthcare Co., Ltd with the FDA for Banded Face Mask.
| Device ID | K223003 |
| 510k Number | K223003 |
| Device Name: | Banded Face Mask |
| Classification | Mask, Surgical |
| Applicant | Hubei Medlink Healthcare Co., Ltd 36F, Tower1, New World International Trade Tower 568 Jianshe Avenue Wuhan, CN 430000 |
| Contact | Niki Wang |
| Correspondent | Cheng Luo CL 3D Devices LLC 10420 Overgate Place Potomac, MD 20854 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-29 |
| Decision Date | 2022-11-18 |