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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 K192111
Device Name Biodegradable Nitrile Examination Powder Free Glove, Green
Applicant
Top Glove Sdn. Bhd.
Lot 4969, Jalan Teratai, Batu 6, Off Jalan Meru
Klang,  MY 41050
Applicant Contact Noor Akilah Saidin
Correspondent
Tg Medical (Usa), Inc.
165, N. Aspan Ave.
Azusa,  CA  91702
Correspondent Contact David Lim
Regulation Number880.6250
Classification Product Code
LZA  
Date Received08/05/2019
Decision Date 09/03/2020
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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