BIOTECH Nitrile Examination Gloves

Polymer Patient Examination Glove

TK Hitech Technology Co., Ltd.

The following data is part of a premarket notification filed by Tk Hitech Technology Co., Ltd. with the FDA for Biotech Nitrile Examination Gloves.

Pre-market Notification Details

Device IDK202419
510k NumberK202419
Device Name:BIOTECH Nitrile Examination Gloves
ClassificationPolymer Patient Examination Glove
Applicant TK Hitech Technology Co., Ltd. 1/221 Venish Irish Iris Watcharaphol Road Tha Rang, Bangkok,  TH 10220
ContactKanyapadsanan Suppipatthipbodee
CorrespondentJoyce Kwon
Provision Consulting Group, Inc. 100 Barranca St. Suite 700 West Covina,  CA  91791
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-24
Decision Date2021-04-16

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