The following data is part of a premarket notification filed by Clover Glove Company Limited with the FDA for Clover Glove.
| Device ID | K213729 |
| 510k Number | K213729 |
| Device Name: | Clover Glove |
| Classification | Polymer Patient Examination Glove |
| Applicant | Clover Glove Company Limited 1999/8 District Sriwara Village, Ladphrao 94 (Punjamit) Sriwara Rd, Plabphla Wang Thong Lang, TH 10240 |
| Contact | Pongsin Pongwachirint |
| 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 | 2021-11-26 |
| Decision Date | 2022-03-26 |