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 |