The following data is part of a premarket notification filed by Hubei Kimsoul Industrial Co., Ltd with the FDA for Surgical Face Mask (non-sterile).
| Device ID | K212398 |
| 510k Number | K212398 |
| Device Name: | Surgical Face Mask (Non-sterile) |
| Classification | Mask, Surgical |
| Applicant | Hubei Kimsoul Industrial Co., Ltd NO. 1, Industrial Zone, Guohe Town Xiantao, CN 433013 |
| Contact | Faming Zhang |
| Correspondent | Grace Liu Shenzhen Joyantech Consulting Co. Ltd 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, CN 518000 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-02 |
| Decision Date | 2021-12-15 |