The following data is part of a premarket notification filed by Guangdong Zhizhen Biological Medical Co., Ltd with the FDA for Surgical Mask.
| Device ID | K212997 |
| 510k Number | K212997 |
| Device Name: | Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Guangdong Zhizhen Biological Medical Co., Ltd 3rd And 4th Floors Of Building 2 & 1 St And 3rd Floors of Building, No. 5, South Street, Dayan First Team Guangzhou, CN 510820 |
| Contact | Caiyun Zhou |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-20 |
| Decision Date | 2022-01-14 |