The following data is part of a premarket notification filed by Gemtier Medical (shanghai) Inc with the FDA for Medical Face Mask.
| Device ID | K202493 |
| 510k Number | K202493 |
| Device Name: | Medical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Gemtier Medical (Shanghai) Inc No.18 Jianding Road, Fengjing Town, Jinshan District Shanghai, CN 201502 |
| Contact | Li Zhiqing |
| Correspondent | Julie Chen Shanghai Medical Business Consulting Co., Ltd. No. 170 Huajiang Road, Jiading District Shanghai, CN 201803 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-31 |
| Decision Date | 2021-02-04 |