The following data is part of a premarket notification filed by Nanjing 3h Medical Products Co., Ltd. with the FDA for Surgical Mask (sterile).
| Device ID | K211295 |
| 510k Number | K211295 |
| Device Name: | Surgical Mask (sterile) |
| Classification | Mask, Surgical |
| Applicant | Nanjing 3H Medical Products Co., Ltd. No.5 Zhushan Road Gaochun County Economic Development Zone Nanjing, CN 211300 |
| Contact | Chun Yang |
| Correspondent | Chun Yang Nanjing 3H Medical Products Co., Ltd. No.5 Zhushan Road Gaochun County Economic Development Zone Nanjing, CN 211300 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-28 |
| Decision Date | 2021-11-24 |