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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K202419
Device Name BIOTECH Nitrile Examination Gloves
Applicant
Tk Hitech Technology Co., Ltd.
1/221 Venish Irish Iris Watcharaphol Rd.
Tha Rang, Bangkok,  TH 10220
Applicant Contact Kanyapadsanan Suppipatthipbodee
Correspondent
Provision Consulting Group, Inc.
100 Barranca St. Suite 700
West Covina,  CA  91791
Correspondent Contact Joyce Kwon
Regulation Number880.6250
Classification Product Code
LZA  
Date Received08/24/2020
Decision Date 04/16/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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