The following data is part of a premarket notification filed by Hycare International Co., Ltd with the FDA for Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves.
| Device ID | K211209 |
| 510k Number | K211209 |
| Device Name: | Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Hycare International Co., Ltd 1197 Moo 3, Asia Highway Khuanlang Hatyai, TH 90110 |
| Contact | Tippawan Phongpheaw |
| Correspondent | Sebastian Feye Accurate Consulting Inc. 3234 Ibis Street San Diego, CA 92103 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-23 |
| Decision Date | 2021-12-17 |