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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 K982579
Device Name LATEX EXAMINATION GLOVES POWDER FREE
Applicant
Shiva Medicare , Ltd.
Box 3721
Crofton,  MD  21114
Applicant Contact JAMES F LOGAN
Correspondent
Shiva Medicare , Ltd.
Box 3721
Crofton,  MD  21114
Correspondent Contact JAMES F LOGAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/24/1998
Decision Date 08/11/1998
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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