The following data is part of a premarket notification filed by Wellmed Dental Medical Supply Co., Ltd. with the FDA for Disposable Medical Face Mask (df3-001).
| Device ID | K222697 |
| 510k Number | K222697 |
| Device Name: | Disposable Medical Face Mask (DF3-001) |
| Classification | Mask, Surgical |
| Applicant | Wellmed Dental Medical Supply Co., Ltd. 301 Zhongxing Science And Technology Building,No.64, Xin’an 2nd Road, Baoan District Shenzhen, CN |
| Contact | Tang Renxian |
| Correspondent | Jarvis Wu Shanghai Sungo Management Consulting Company Limited 14th F, 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 | 2022-09-07 |
| Decision Date | 2022-11-04 |