The following data is part of a premarket notification filed by Thai Rubber Gloves Co., Ltd with the FDA for Goody Gloves, Wincare, Tbg Gloves.
| Device ID | K213073 |
| 510k Number | K213073 |
| Device Name: | Goody Gloves, Wincare, TBG Gloves |
| Classification | Latex Patient Examination Glove |
| Applicant | Thai Rubber Gloves Co., Ltd 680 Moo 2 Banbueng-Klaeng Rd. Nongyai, TH 20190 |
| Contact | Chalongkwan Wongsasuthikul |
| Correspondent | Manoj Zacharias Liberty Management Group Ltd. 75 Executive Dr. STE 114, Aurora, IL 60504 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-23 |
| Decision Date | 2021-12-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18859705100022 | K213073 | 000 |