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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name vinyl patient examination glove
510(k) Number K113749
Device Name DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR
Original Applicant
FULL SYNERGY MEDICAL PRODUCTS INC
5748 eaglewood place
rancho cucamonga,  CA  91739
Original Contact elizabeth deng
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received12/21/2011
Decision Date 03/15/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
statement statement
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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