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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K982586
Device Name POWDER FREE SURGEONS GLOVE
Applicant
Shiva Medicare , Ltd.
314 N Huntet St.
Baltimore,  MD  21202
Applicant Contact JAMES F LOGAN
Correspondent
Shiva Medicare , Ltd.
314 N Huntet St.
Baltimore,  MD  21202
Correspondent Contact JAMES F LOGAN
Regulation Number878.4460
Classification Product Code
KGO  
Date Received07/24/1998
Decision Date 08/11/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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