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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 K153732
Device Name Powder Free Blue Nitrile Examination Glove
Applicant
QUBE MEDICAL PRODUCT SDN BHD
NO. 9, JALAN KPK 1/1, KAWASAN PERINDUSTRIAN KUNDANG
RAWANG,  MY 48020
Applicant Contact TEO SIONG YAM
Correspondent
QUBE MEDICAL PRODUCT SDN BHD
NO. 9, JALAN KPK 1/1, KAWASAN PERINDUSTRIAN KUNDANG
RAWANG,  MY 48020
Correspondent Contact DAVENDRAN TANGAYA
Regulation Number880.6250
Classification Product Code
LZA  
Date Received12/28/2015
Decision Date 07/29/2016
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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