The following data is part of a premarket notification filed by Sunsmed Protective Products Ltd. with the FDA for Surgical Face Mask.
| Device ID | K211296 |
| 510k Number | K211296 |
| Device Name: | Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Sunsmed Protective Products Ltd. No.18, Industrial Park, Maozui Town Xinatao, CN 433000 |
| Contact | Joyce Lee |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No.738, Shangcheng Rd., Pudong Shanghai, CN 200120 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-28 |
| Decision Date | 2021-09-11 |