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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K040071
Device Name ENNOBLE DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN
Applicant
Elite International, Inc.
18709 Greenbay Dr.
Rowland Heights,  CA  91748
Applicant Contact BOBBY LING
Correspondent
Elite International, Inc.
18709 Greenbay Dr.
Rowland Heights,  CA  91748
Correspondent Contact BOBBY LING
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received01/14/2004
Decision Date 06/03/2004
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
Predetermined Change
Control Plan Authorized		 No
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