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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 K101645
Device Name NON-CHLORINATED, POLYMER COATED POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES AND PROTEIN LABELING CLAIM OF
Applicant
Latexx Manufacturing Sdn.Bhd.
Pt. 5054,
Kamunting Industrial Estate
Taiping, Perak,  MY 34600
Applicant Contact TERENCE LIM SIN KOOI
Correspondent
Latexx Manufacturing Sdn.Bhd.
Pt. 5054,
Kamunting Industrial Estate
Taiping, Perak,  MY 34600
Correspondent Contact TERENCE LIM SIN KOOI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/11/2010
Decision Date 08/26/2010
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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