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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K071740
Device Name CHLORINATED POWDER FREE NITRILE LATEX EXAMINATION GLOVES
Applicant
Medtexx Manufacturing Sdn. Bhd.
Pt 4004 Kamunting Indu. Estate
Kamunting, Taiping, Perak,  MY 34600
Applicant Contact OOI LOON SENG
Correspondent
Medtexx Manufacturing Sdn. Bhd.
Pt 4004 Kamunting Indu. Estate
Kamunting, Taiping, Perak,  MY 34600
Correspondent Contact OOI LOON SENG
Regulation Number880.6250
Classification Product Code
LZA  
Date Received06/27/2007
Decision Date 10/04/2007
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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