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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 K062138
Device Name POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPRENE STERILE EXAMINATION GLOVE
Applicant
Molnlycke Health Care, Inc.
5550 Peachtree Pkwy., Suite 500
Norcross,  GA  30092
Applicant Contact STEVE DOWDLEY
Correspondent
Molnlycke Health Care, Inc.
5550 Peachtree Pkwy., Suite 500
Norcross,  GA  30092
Correspondent Contact STEVE DOWDLEY
Regulation Number880.6250
Classification Product Code
LZA  
Date Received07/26/2006
Decision Date 10/05/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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