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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 K113100
Device Name POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Applicant
MAXTER GLOVE MANUFACTURING SDN BHD
LOT 6070, JALAN HAJI ABDUL
MANAN, 6TH MILES OFF JALAN
MERU, KLANG,  MY 41050
Applicant Contact YAP P GEEH
Correspondent
MAXTER GLOVE MANUFACTURING SDN BHD
LOT 6070, JALAN HAJI ABDUL
MANAN, 6TH MILES OFF JALAN
MERU, KLANG,  MY 41050
Correspondent Contact YAP P GEEH
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received10/19/2011
Decision Date 02/06/2012
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
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