Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves

Polymer Patient Examination Glove

Hycare International Co., Ltd

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.

Pre-market Notification Details

Device IDK211209
510k NumberK211209
Device Name:Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves
ClassificationPolymer Patient Examination Glove
Applicant Hycare International Co., Ltd 1197 Moo 3, Asia Highway Khuanlang Hatyai,  TH 90110
ContactTippawan Phongpheaw
CorrespondentSebastian Feye
Accurate Consulting Inc. 3234 Ibis Street San Diego,  CA  92103
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-23
Decision Date2021-12-17

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.