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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medical Glove, Specialty
510(k) Number K033789
Device Name LATEX POWDER-FREE EXAMINATION GLOVES WITH COATING
Applicant
Cardinalhealth
1500 Waukegan Rd.
Bldg. Wm
Mcgaw Park,  IL  60085
Applicant Contact ERICA SETHI
Correspondent
Cardinalhealth
1500 Waukegan Rd.
Bldg. Wm
Mcgaw Park,  IL  60085
Correspondent Contact ERICA SETHI
Regulation Number880.6250
Classification Product Code
LZC  
Date Received12/04/2003
Decision Date 05/07/2004
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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