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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 K011446
Device Name BARRIERPLUS POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES
Applicant
Barriermed, Inc.
2500 W. Lake Mary Blvd.,#111
Lake Mary,  FL  32746
Applicant Contact CARLO PONCIPE
Correspondent
Barriermed, Inc.
2500 W. Lake Mary Blvd.,#111
Lake Mary,  FL  32746
Correspondent Contact CARLO PONCIPE
Regulation Number878.4460
Classification Product Code
KGO  
Date Received05/11/2001
Decision Date 06/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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