The following data is part of a premarket notification filed by Shandong Zhushi Pharmaceutical Group Co., Ltd with the FDA for Disposable Surgical Face Mask.
| Device ID | K210643 |
| 510k Number | K210643 |
| Device Name: | Disposable Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Shandong Zhushi Pharmaceutical Group Co., Ltd No.6 Shande Road, Shan County Heze, CN 274300 |
| Contact | Junhui Zhu |
| 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 | 2021-03-03 |
| Decision Date | 2021-08-04 |