The following data is part of a premarket notification filed by Shandong Aida Medical Products Co., Ltd with the FDA for Disposable Surgical Face Mask.
| Device ID | K220302 |
| 510k Number | K220302 |
| Device Name: | Disposable Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Shandong Aida Medical Products Co., Ltd Wangjiazhuang, Wangliu Strret Office, Weicheng District Weifang, CN 261053 |
| Contact | Wang Bing |
| Correspondent | Wang Bing Shandong Aida Medical Products Co., Ltd Wangjiazhuang, Wangliu Street Office, Weicheng District Weifang, CN 261053 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-02 |
| Decision Date | 2022-11-16 |