The following data is part of a premarket notification filed by Shandong Shengquan New Materials Co., Ltd. with the FDA for Surgical Mask.
| Device ID | K211552 |
| 510k Number | K211552 |
| Device Name: | Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Shandong Shengquan New Materials Co., Ltd. Diaozhen Industrial Development Zone, Zhangqiu District Jinan, CN 250204 |
| Contact | Xiumei Zhang |
| Correspondent | Daniel Qiu Shanghai Qisheng Business Consulting Co., Ltd. Room 1301, Bld 46, Jing Gu Zhong Rd. No.58, Min Hang District Shanghai, CN 200240 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-19 |
| Decision Date | 2021-08-11 |