The following data is part of a premarket notification filed by Jiangxi Sanhao Medical Instruments Co.,ltd with the FDA for Surgical Mask (model: 0868f, 0866f).
| Device ID | K221173 |
| 510k Number | K221173 |
| Device Name: | Surgical Mask (Model: 0868F, 0866F) |
| Classification | Mask, Surgical |
| Applicant | Jiangxi SanHao Medical Instruments Co.,Ltd Chengxi Industrial Park, Jishui County, Ji'an City Ji'an, CN 331699 |
| Contact | Jiali Chen |
| Correspondent | Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District Guangzhou, CN |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-25 |
| Decision Date | 2022-07-06 |