The following data is part of a premarket notification filed by Jiangxi Ganlong Pharmaceutical Co.,ltd. with the FDA for Surgical Face Mask.
| Device ID | K212913 |
| 510k Number | K212913 |
| Device Name: | Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Jiangxi Ganlong Pharmaceutical Co.,Ltd. No. 164 Xiangjiang Ave. Ganzhou Economic And Technology Development Zone Ganzhou, CN 341000 |
| Contact | Niansheng Liao |
| Correspondent | Stuart Situ Landlink Healthcare Technology (Shanghai) Co., Ltd. Room 1308, Baohua International Plaza, West Guangzhong Road Shanghai, CN 200071 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-13 |
| Decision Date | 2022-01-14 |