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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 K063524
Device Name POWDER FREE NITRILE EXAMINATION GLOVES (WHITE AND BLUE COLOR)
Applicant
Hl Rubber Industries Sdn Bhd
Lot 10, Kawasan
Perindustrian Dioh
Kuala Pilah, Negeri Sembilan,  MY 72000
Applicant Contact KENNY HOE
Correspondent
Hl Rubber Industries Sdn Bhd
Lot 10, Kawasan
Perindustrian Dioh
Kuala Pilah, Negeri Sembilan,  MY 72000
Correspondent Contact KENNY HOE
Regulation Number880.6250
Classification Product Code
LZA  
Date Received11/22/2006
Decision Date 01/23/2007
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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