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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 K032016
Device Name DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES COATED WITH ALPHA LIPOIC ACID AND VITAMIN E, AND WITH PROTEIN CONTENT
Applicant
Wrp Specialty Products Sdn. Bhd.
Lot 11, Jalan 2, Kawasan
Perusahaan Bandar Baru, Salak
Tinggi, Sepang, Selangor,  MY 43900
Applicant Contact V. NADARAJAN
Correspondent
Wrp Specialty Products Sdn. Bhd.
Lot 11, Jalan 2, Kawasan
Perusahaan Bandar Baru, Salak
Tinggi, Sepang, Selangor,  MY 43900
Correspondent Contact V. NADARAJAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/30/2003
Decision Date 05/11/2004
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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