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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 K213729
Device Name Clover Glove
Applicant
Clover Glove Company Limited
1999/8 District Sriwara Village, Ladphrao 94 (Punjamit)
Sriwara Rd, Plabphla
Wang Thong Lang,  TH 10240
Applicant Contact Pongsin Pongwachirint
Correspondent
Liberty Management Group Limited
75 Executive Drive, Suite 114
Aurora,  IL  60504
Correspondent Contact Manoj Zacharias
Regulation Number880.6250
Classification Product Code
LZA  
Date Received11/26/2021
Decision Date 03/26/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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