The following data is part of a premarket notification filed by Xianning Eco Medical Articles Co., Ltd. with the FDA for Ecoma Level 2 Disposable Surgical Mask With Ear Loops.
| Device ID | K210698 |
| 510k Number | K210698 |
| Device Name: | ECOMA Level 2 Disposable Surgical Mask With Ear Loops |
| Classification | Mask, Surgical |
| Applicant | Xianning Eco Medical Articles Co., Ltd. No.16,Shutai Street High-Tech Industrial Zone Xianning, CN 437000 |
| Contact | Wei Zhou |
| Correspondent | Wei Zhou Xianning Eco Medical Articles Co., Ltd. No.16,Shutai Street High-Tech Industrial Zone Xianning, CN 437000 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-08 |
| Decision Date | 2021-08-19 |