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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K013942
Device Name POWDER FREE BLUE LATEX EXAMINATION GLOVE, NON-STERILE (PROTEIN CONTENT LABELING)
Applicant
Wrp Specialty Products Sdn. Bhd.
Lot11 Jalan2 Perusahaan Bandar
Kawasan Baru Salak Tinggi
Sepang, Selangor,  MY 43900
Applicant Contact MOHD H HUSSEIN
Correspondent
Wrp Specialty Products Sdn. Bhd.
Lot11 Jalan2 Perusahaan Bandar
Kawasan Baru Salak Tinggi
Sepang, Selangor,  MY 43900
Correspondent Contact MOHD H HUSSEIN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/29/2001
Decision Date 12/31/2001
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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