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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 K003132
Device Name DERMAGRIP POWDER FREE BLUE POLYMER COATED LATEX EXAMINATION GLOVE, NON-STERILE CONTAINS 50 MICROGRAM OR LESS OF TOTAL WA
Applicant
WRP SPECIALTY PRODUCTS SDN. BHD.
LOT11, JL.2,KAWASAN PERUSAHAAN
BANDAR BARU SLAK TINGGI
SELANGOR DAURL EHSAN, SEPANG,  MY 43900
Applicant Contact MOHD HAIZAN HUSSEIN
Correspondent
WRP SPECIALTY PRODUCTS SDN. BHD.
LOT11, JL.2,KAWASAN PERUSAHAAN
BANDAR BARU SLAK TINGGI
SELANGOR DAURL EHSAN, SEPANG,  MY 43900
Correspondent Contact MOHD HAIZAN HUSSEIN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/06/2000
Decision Date 11/17/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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