The following data is part of a premarket notification filed by Thanh Cong Pharmaceutical And Trading Company Limited with the FDA for Tc Gloves.
| Device ID | K221186 |
| 510k Number | K221186 |
| Device Name: | TC Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Thanh Cong Pharmaceutical And Trading Company Limited KM6+ 200 National Road No. 38, Hap Linh Bac Ninh City, VN |
| Contact | Nguyen Thi Tu Anh |
| Correspondent | Manoj Zacharias Liberty Management Group Limited 75 Executive Drive, Suite 114 Aurora, IL 60504 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-25 |
| Decision Date | 2022-06-16 |