The following data is part of a premarket notification filed by Jiangsu Nanfang Medical Co., Ltd. with the FDA for Disposable Medical Mask.
| Device ID | K212826 |
| 510k Number | K212826 |
| Device Name: | Disposable Medical Mask |
| Classification | Mask, Surgical |
| Applicant | Jiangsu Nanfang Medical Co., Ltd. No. 1 Guoxiang Road, Wujin Economic Development Zone, Wujin Changzhou, CN 213149 |
| Contact | Li Xia |
| Correspondent | Charles Mack Irc 2950 E Lindrick Drive Chandler, AZ 85249 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-03 |
| Decision Date | 2022-01-19 |