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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 K193150
Device Name Latex Examination Powder Free Glove, Aloe Vera
Applicant
Top Glove SDN BHD
Lot 4969, Jalan Teratai, Batu 6, Off Jalan Meru
Klang,  MY 41050
Applicant Contact Noor Akilah BT Saidin
Correspondent
TG Medical (USA) Inc
165, North Aspan Avenue
Azusa,  CA  91702
Correspondent Contact David Lim
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LYY  
Date Received11/13/2019
Decision Date 06/05/2020
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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