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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 K042817
Device Name MICRO-TOUCH SMOOTH NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE)
Applicant
ANSELL HEALTHCARE PRODUCTS, INC.
1635 INDUSTRIAL ROAD
DOTHAN,  AL  36303
Applicant Contact LON D MCLLVAIN
Correspondent
ANSELL HEALTHCARE PRODUCTS, INC.
1635 INDUSTRIAL ROAD
DOTHAN,  AL  36303
Correspondent Contact LON D MCLLVAIN
Regulation Number880.6250
Classification Product Code
LZA  
Date Received10/12/2004
Decision Date 12/06/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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