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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 K123116
Device Name CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES (BLACK COLOUR)
Applicant
Worldmed Manufacturing Sdn. Bhd.
Lot 18873, Jalan Perusahaan3,
Kamunting Industrial Estate, Kamunting
Kamunting,  MY 34600
Applicant Contact OOI LOON SENG
Correspondent
Worldmed Manufacturing Sdn. Bhd.
Lot 18873, Jalan Perusahaan3,
Kamunting Industrial Estate, Kamunting
Kamunting,  MY 34600
Correspondent Contact OOI LOON SENG
Regulation Number880.6250
Classification Product Code
LZA  
Date Received10/03/2012
Decision Date 02/11/2013
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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