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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K060733
Device Name SYNTHALON PI POWDER-FREE SYNTHETIC POLYISOPRENE/POLYCHLOROPRENE EXAMINATION GLOVES MDL 1362-10 TO 1362-44
Applicant
Barriermed, Inc.
155 Technology Park
Lake Mary,  FL  32746
Applicant Contact VICTOR RAGUCCI
Correspondent
Barriermed, Inc.
155 Technology Park
Lake Mary,  FL  32746
Correspondent Contact VICTOR RAGUCCI
Regulation Number880.6250
Classification Product Code
LZA  
Date Received03/20/2006
Decision Date 04/24/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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