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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 K910928
Device Name RUBBER LATEX SURGEONS GLOVES
Applicant
Regent Hospital Products
C/O Arent-Fox-Kint-Plotk-Kahn
1050 Connecticut Ave., NW
Washington,  DC  20036
Applicant Contact WAYNE H MATELSKI
Correspondent
Regent Hospital Products
C/O Arent-Fox-Kint-Plotk-Kahn
1050 Connecticut Ave., NW
Washington,  DC  20036
Correspondent Contact WAYNE H MATELSKI
Regulation Number878.4460
Classification Product Code
KGO  
Date Received03/05/1991
Decision Date 06/13/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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