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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 K122874
Device Name POWDERED NITRILE EXAMINATION GLOVES, BLUE AND WHITE
Applicant
Nitrilist Gloves Manufacturing Sdn Bhd
Pt 197, Kawasan Perindustrian Dioh
Kuala Pilah,  MY 72000
Applicant Contact LAU SIONG HUT
Correspondent
Nitrilist Gloves Manufacturing Sdn Bhd
Pt 197, Kawasan Perindustrian Dioh
Kuala Pilah,  MY 72000
Correspondent Contact LAU SIONG HUT
Regulation Number880.6250
Classification Product Code
LZA  
Date Received09/19/2012
Decision Date 12/10/2012
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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