The following data is part of a premarket notification filed by Nantong Taiweishi Medical Technology Co., Ltd. with the FDA for Surgical Face Mask.
| Device ID | K212264 |
| 510k Number | K212264 |
| Device Name: | Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Nantong Taiweishi Medical Technology Co., Ltd. Taihangshan Road, New District, Economic Development Zone, Rudong County Nantong, CN 226400 |
| Contact | Zhang Xuewen |
| Correspondent | Eva Li Shanghai Sungo Management Consulting Company Limited Room 1309, Dongfang Building, 1500#Century Ave Shanghai, CN 200122 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-20 |
| Decision Date | 2021-11-13 |