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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 K891658
Device Name REGENT BIOGEL D(TM) NON-STERILE DENTAL GLOVES
Applicant
Regent Hospital Products
Washington Sq.
1050 Connecticut Ave. NW
Washington,  DC  20036
Applicant Contact WAYNE H MATELSKI
Correspondent
Regent Hospital Products
Washington Sq.
1050 Connecticut Ave. NW
Washington,  DC  20036
Correspondent Contact WAYNE H MATELSKI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/20/1989
Decision Date 06/06/1989
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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