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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 K220693
Device Name Zoupure Nitrile Powder Free Examination glove
Applicant
Thai Rayong Product Glove Zoupure Co., Ltd
168 moo.1 Nongbua
Bankhai,  TH 21120
Applicant Contact Rattiya Pitutacha
Correspondent
Regulatory Insight, Inc.
33 Golden Eagle Lane
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number880.6250
Classification Product Code
LZA  
Date Received03/09/2022
Decision Date 06/07/2022
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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