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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name surgeon's gloves
510(K) Number K113707
Device Name STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING
Applicant
CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES
1430 waukegan rd.
mcgaw park,  IL  60085
Contact tatyana bogdan
Regulation Number878.4460
Classification Product Code
KGO  
Date Received12/16/2011
Decision Date 04/27/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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