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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K032647
Device Name ALOETOUCH POWDER FREE NEOPRENE SURGICAL GLOVES, STERILE, TURQUOISE COLOUR AND COATED WITH ALOE VERA
Applicant
Wrp Asia Pacific Sdn. Bhd.
Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi
Sepang,  MY 43900
Applicant Contact TERENCE LIM
Correspondent
Wrp Asia Pacific Sdn. Bhd.
Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi
Sepang,  MY 43900
Correspondent Contact TERENCE LIM
Regulation Number878.4460
Classification Product Code
KGO  
Date Received08/27/2003
Decision Date 11/07/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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