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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K052666
Device Name NON-STERILE POWDER FREE NATURAL/GREEN LANO-E LATEX EXAM GLOVES, WITH OR WIHOUT CITRUS/PEPPERMINT SCENT PLUS A PROTEIN
Applicant
Ascend Eagle, Inc.
140-B Dodd Ct.
American Canyon,  CA  94503
Applicant Contact JARILYN LIM
Correspondent
Ascend Eagle, Inc.
140-B Dodd Ct.
American Canyon,  CA  94503
Correspondent Contact JARILYN LIM
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/27/2005
Decision Date 01/25/2006
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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