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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 K122999
Device Name POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Applicant
Top Glove Sdn. Bhd.
Lot 4968, Batu 6,Jalan Teratai
Off Jalan Meru
Klang, Selangor,  MY 41050
Applicant Contact EDDY ROSAYDIE
Correspondent
Top Glove Sdn. Bhd.
Lot 4968, Batu 6,Jalan Teratai
Off Jalan Meru
Klang, Selangor,  MY 41050
Correspondent Contact EDDY ROSAYDIE
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received09/27/2012
Decision Date 11/30/2012
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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