The following data is part of a premarket notification filed by Haian Medigauze Co., Ltd with the FDA for Medical Face Mask.
| Device ID | K212471 |
| 510k Number | K212471 |
| Device Name: | Medical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Haian Medigauze Co., Ltd Jiaoxie Industry Park, Haian Nantong, CN 226633 |
| Contact | Weihua Xu |
| Correspondent | Weihua Xu Haian Medigauze Co., Ltd Jiaoxie Industry Park, Haian Nantong, CN 226633 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-06 |
| Decision Date | 2021-11-04 |