The following data is part of a premarket notification filed by Wealth Lead Industrial Limited with the FDA for 3-ply Disposable Medical Mask.
| Device ID | K223045 |
| 510k Number | K223045 |
| Device Name: | 3-Ply Disposable Medical Mask |
| Classification | Mask, Surgical |
| Applicant | Wealth Lead Industrial Limited 2/F, Kras Asia Industrial Building, 79 Hung To Road Kwun Tong, KL Hong Kong, CN 0000 |
| Contact | Ethel Chiu Man Mok |
| Correspondent | Ivy Lai Wealth Lead Industrial Limited 2/F, Kras Asia Industrial Building, 79 Hung To Road Kwun Tong, KL Hong Kong, CN 0000 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-29 |
| Decision Date | 2022-12-07 |