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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 K002593
Device Name POWDER FREE STERILE LATEX SURGICAL GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
Applicant
HARTALEGA SDN BHD
9 JALAN KUANG BULAN TAMAN
KEPONG INDUSTRIAL ESTATE
KUALA LUMPUR,  MY 52100
Applicant Contact NURUL A KONG
Correspondent
HARTALEGA SDN BHD
9 JALAN KUANG BULAN TAMAN
KEPONG INDUSTRIAL ESTATE
KUALA LUMPUR,  MY 52100
Correspondent Contact NURUL A KONG
Regulation Number878.4460
Classification Product Code
KGO  
Date Received08/21/2000
Decision Date 11/29/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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