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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K984615
Device Name POWDERED NITRILE EXAMINATION GLOVES
Applicant
Shiva Medicare , Ltd.
314 N. Hunter St.
Baltimore,  MD  21202
Applicant Contact JAMES F LOGAN
Correspondent
Shiva Medicare , Ltd.
314 N. Hunter St.
Baltimore,  MD  21202
Correspondent Contact JAMES F LOGAN
Regulation Number880.6250
Classification Product Code
LZA  
Date Received12/29/1998
Decision Date 02/17/1999
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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