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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 K031754
Device Name FLEXISKIN POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE
Applicant
PT. MANDIRI INTI BUANA
JL. LISTRIK NO. 6
MEDAN,  ID 20112
Applicant Contact NG POY SIN
Correspondent
PT. MANDIRI INTI BUANA
JL. LISTRIK NO. 6
MEDAN,  ID 20112
Correspondent Contact NG POY SIN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/31/2003
Decision Date 06/30/2003
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
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