The following data is part of a premarket notification filed by Jiangxi 3l Medical Products Group Co., Ltd with the FDA for Surgical Face Mask.
| Device ID | K202277 |
| 510k Number | K202277 |
| Device Name: | Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Jiangxi 3L Medical Products Group Co., Ltd No.599, Huoju Street, High-tech Development Zone Nanchang City, CN 330029 |
| Contact | Ge Zhang |
| 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 | 2020-08-11 |
| Decision Date | 2020-09-25 |