The following data is part of a premarket notification filed by Everwin Toys (dongguan)., Ltd. with the FDA for Disposable Medical Mask.
| Device ID | K203388 |
| 510k Number | K203388 |
| Device Name: | Disposable Medical Mask |
| Classification | Mask, Surgical |
| Applicant | Everwin Toys (Dongguan)., Ltd. Xiekeng Village, Qingxi Town Dongguan, CN 523000 |
| Contact | Huang Zibin |
| Correspondent | Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District Guangzhou, CN 510700 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-18 |
| Decision Date | 2021-06-04 |