The following data is part of a premarket notification filed by Rfx+care Manufactoring Co., Ltd. with the FDA for Surgical Face Mask.
| Device ID | K203190 |
| 510k Number | K203190 |
| Device Name: | Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | RFX+CARE Manufactoring Co., Ltd. 7 Lanjiang Road, Yuecheng District Shao Xing, CN 312000 |
| Contact | Zhou Xiufeng |
| Correspondent | James Tsai 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 | 2020-10-27 |
| Decision Date | 2021-06-02 |