The following data is part of a premarket notification filed by Xiantao Topmed Nonwoven Protective Products Co., Ltd. with the FDA for Disposable Medical Face Mask (ear Loop).
| Device ID | K221196 |
| 510k Number | K221196 |
| Device Name: | Disposable Medical Face Mask (ear Loop) |
| Classification | Mask, Surgical |
| Applicant | Xiantao Topmed Nonwoven Protective Products Co., Ltd. North Of The National Road 318, Tongjiazui Village,Huchang Town Xiantao, CN 433000 |
| Contact | Vivian Zhu |
| Correspondent | Ivy Wang Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Century Avenue 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 | 2022-04-25 |
| Decision Date | 2022-07-22 |