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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 K060771
Device Name POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE,WHITE (NON-COLORED) AND BLUE COLORED
Applicant
Kossan Latex Industries(M)Sdn Bhd
Lot 16632, 5-1/4 Miles,
Jalan Meru
Klang, Selangor,  MY 41050
Applicant Contact LIM K HWA
Correspondent
Kossan Latex Industries(M)Sdn Bhd
Lot 16632, 5-1/4 Miles,
Jalan Meru
Klang, Selangor,  MY 41050
Correspondent Contact LIM K HWA
Regulation Number880.6250
Classification Product Code
LZA  
Date Received03/22/2006
Decision Date 05/01/2006
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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