The following data is part of a premarket notification filed by Anhui Jbh Medical Apparatus Co., Ltd. with the FDA for Disposable Medical Mask.
| Device ID | K210302 |
| 510k Number | K210302 |
| Device Name: | Disposable Medical Mask |
| Classification | Mask, Surgical |
| Applicant | Anhui JBH Medical Apparatus Co., Ltd. No. 116 Qicang Road, Mingguang City Chuzhou, CN 239400 |
| Contact | Dandan Yang |
| Correspondent | Eva Li Shanghai Sungo Management Consulting Company Limited Room 1309, Dongfang Building, 1500# Century Ave Shanghai, CN 200122 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-03 |
| Decision Date | 2021-05-14 |