The following data is part of a premarket notification filed by Jiangsu Xingtong Biotechnology Group Co., Ltd. with the FDA for Surgical Mask.
| Device ID | K211454 |
| 510k Number | K211454 |
| Device Name: | Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Jiangsu Xingtong Biotechnology Group Co., Ltd. No.8, Kele Road, Touqiao Area, Beizhou Industrial Park, Guangling Zone Yangzhou, CN 225000 |
| Contact | Li Hua |
| 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 | 2021-05-10 |
| Decision Date | 2021-08-18 |