The following data is part of a premarket notification filed by Nantong Taiweishi Medical Technology Co., Ltd. with the FDA for Surgical Face Mask (non-sterile).
| Device ID | K203426 |
| 510k Number | K203426 |
| Device Name: | Surgical Face Mask (non-sterile) |
| Classification | Mask, Surgical |
| Applicant | Nantong Taiweishi Medical Technology Co., Ltd. Taihangshan Road, New District, Economic Development Zone, Rudong County Nan Tong, CN 226400 |
| Contact | Zhang Xuewen |
| Correspondent | Mandy Wu Shanghai Sungo Management Consulting Company Limited 13th Floor, 1500# Central Avenue Shangghai, 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 | 2020-11-20 |
| Decision Date | 2021-02-18 |