The following data is part of a premarket notification filed by Zhongshan Saifute Labor Protective Articles Co., Ltd with the FDA for Surgical Face Mask.
| Device ID | K212059 |
| 510k Number | K212059 |
| Device Name: | Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Zhongshan Saifute Labor Protective Articles CO., LTD No.7, Xihuan 4th Road, Southern District Zhongshan, CN 528400 |
| Contact | Qionghua Ke |
| Correspondent | Qionghua Ke Zhongshan Saifute Labor Protective Articles CO., LTD No.7, Xihuan 4th Road, Southern District Zhongshan, CN 528400 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-01 |
| Decision Date | 2021-12-17 |