The following data is part of a premarket notification filed by Nanchang Kanghua Health Materials Co., Ltd with the FDA for Medical Surgical Mask.
| Device ID | K212867 |
| 510k Number | K212867 |
| Device Name: | Medical Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Nanchang Kanghua Health Materials Co., Ltd Moonlight Road,Medical Device Technology Park, Jinxian County Nanchang, CN 331700 |
| Contact | Jiamin Wang |
| Correspondent | Doris Chen Shanghai Jiushun Enterprise Management Technology Service Co., Ltd. Room 1502,BaoAn Building,No.800 Dongfang Road 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 | 2021-09-08 |
| Decision Date | 2021-12-11 |