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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 K083156
Device Name NON STERILE POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
Applicant
Giga-Drive Sdn, Bhd
17a Jalan Dato Haji Megat Khas
Taman Bandar Utama
Ipoh, Perak,  MY 31400
Applicant Contact IAN NG TZE CHEU
Correspondent
Giga-Drive Sdn, Bhd
17a Jalan Dato Haji Megat Khas
Taman Bandar Utama
Ipoh, Perak,  MY 31400
Correspondent Contact IAN NG TZE CHEU
Regulation Number880.6250
Classification Product Code
LZA  
Date Received10/24/2008
Decision Date 05/08/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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