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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 K121844
Device Name POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES
Original Applicant
WORLDMED MANUFACTURING SDN. BHD.
lot 18873, jalan perusahaan
3, kamunting industrial estate
kamunting,  MY 34600
Original Contact chandrasegaran
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/25/2012
Decision Date 09/06/2013
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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