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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 K905755
Device Name NON-STERILE PATIENT EXAMINATION GLOVES
Applicant
Superior Healthcare Group, Inc.
Cumberland Industrial Park
Cumberland,  RI  02864
Applicant Contact MAUREEN G MCCABE
Correspondent
Superior Healthcare Group, Inc.
Cumberland Industrial Park
Cumberland,  RI  02864
Correspondent Contact MAUREEN G MCCABE
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/27/1990
Decision Date 03/08/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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