The following data is part of a premarket notification filed by Hubei Wanli Protective Products Co. Ltd with the FDA for Disposable Medical Mask.
| Device ID | K214085 |
| 510k Number | K214085 |
| Device Name: | Disposable Medical Mask |
| Classification | Mask, Surgical |
| Applicant | Hubei Wanli Protective Products Co. Ltd Yuanshi, Ganhe Xiantao, CN 433000 |
| Contact | Andy Wen |
| Correspondent | Ivy Wang Shanghai SUNGO Management Consulting Company Limited. Room 1401, Dongfang Building, 1500# Century Avenue 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 | 2021-12-27 |
| Decision Date | 2022-04-06 |