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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 K140418
Device Name POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE
Applicant
Wrp Rubber Products Sdn Bhd
Lot 3, Jalan 3, Kawasan Perusahaan Bander Baru Salak Tinggi
Sepang ,Selangor Darul Ehsan,  MY 43900
Applicant Contact LIM CHIN YIT
Correspondent
Wrp Rubber Products Sdn Bhd
Lot 3, Jalan 3, Kawasan Perusahaan Bander Baru Salak Tinggi
Sepang ,Selangor Darul Ehsan,  MY 43900
Correspondent Contact LIM CHIN YIT
Regulation Number880.6250
Classification Product Code
LZA  
Date Received02/18/2014
Decision Date 09/03/2014
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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