The following data is part of a premarket notification filed by Jiangsu Excellence Medical Supplies Co., Ltd with the FDA for Disposable Face Mask.
| Device ID | K202905 |
| 510k Number | K202905 |
| Device Name: | Disposable Face Mask |
| Classification | Mask, Surgical |
| Applicant | Jiangsu Excellence Medical Supplies Co., Ltd No.65 Huiling West Road, Zouqu Town, Zhonglou District Changzhou, CN 203144 |
| Contact | Jing Zhu |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O.BOX 120-119 Shanghai, CN 200120 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-29 |
| Decision Date | 2021-03-26 |