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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 K032668
Device Name DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES
Applicant
Kingswell International, Inc.
264 Carbonia Ave.
Walnut,  CA  91789
Applicant Contact D.C. CHANG
Correspondent
Kingswell International, Inc.
264 Carbonia Ave.
Walnut,  CA  91789
Correspondent Contact D.C. CHANG
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received08/28/2003
Decision Date 10/06/2003
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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