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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 K110960
Device Name ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREE
Applicant
Koon Seng Sdn Bhd
5401 S Cottonwood Ct.
Greenwood Village,  CO  80121
Applicant Contact Kevin Walls
Correspondent
Koon Seng Sdn Bhd
5401 S Cottonwood Ct.
Greenwood Village,  CO  80121
Correspondent Contact Kevin Walls
Regulation Number880.6250
Classification Product Code
LZA  
Date Received04/05/2011
Decision Date 07/14/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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