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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 K120934
Device Name PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN CONTENT LABEL CLAIM OF 50 UG/DM OR LESS
Original Applicant
CARDINAL HEALTH, INC.
1430 waukegan road
mcgaw park,  IL  60085
Original Contact tatyana bogdan
Regulation Number878.4460
Classification Product Code
KGO  
Date Received03/28/2012
Decision Date 05/23/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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