The following data is part of a premarket notification filed by Tianchang Kanghui Protective Products Co Ltd with the FDA for Surgical Mask.
| Device ID | K211255 |
| 510k Number | K211255 |
| Device Name: | Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Tianchang Kanghui Protective Products CO LTD No.16 Wayeconomic Development Zone Tianchan, CN 293900 |
| Contact | Mark Wong |
| Correspondent | Ivy Wang Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central 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 | 2021-04-26 |
| Decision Date | 2021-08-28 |