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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 K051378
Device Name POWDER-FREE BLUE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
Applicant
MEDLINE
ONE MEDLINE PLACE
MUNDLELEIN,  IL  60060
Applicant Contact JENNIFER MASON
Correspondent
MEDLINE
ONE MEDLINE PLACE
MUNDLELEIN,  IL  60060
Correspondent Contact JENNIFER MASON
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/26/2005
Decision Date 08/03/2005
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
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