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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 K120963
Device Name POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES
Applicant
Medtexx Manufacturing Sdn. Bhd.
Pt 4004 Jalan Perusahaan 3
Kamunting Industrial Estate
Kamunting,  MY 34600
Applicant Contact OOI LOON SENG
Correspondent
Medtexx Manufacturing Sdn. Bhd.
Pt 4004 Jalan Perusahaan 3
Kamunting Industrial Estate
Kamunting,  MY 34600
Correspondent Contact OOI LOON SENG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/30/2012
Decision Date 06/29/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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