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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 K020308
Device Name REGENT BIOGEL SKINSENSE STERILE POWDER-FREE, SYNTHETIC POLYISOPRENE SURGEON'S GLOVE
Applicant
Ssl America'S, Inc.
3585 Engineering Dr.,Suite 200
P.O. Box 926090
Norcross,  GA  30092
Applicant Contact JOYCE NING
Correspondent
Ssl America'S, Inc.
3585 Engineering Dr.,Suite 200
P.O. Box 926090
Norcross,  GA  30092
Correspondent Contact JOYCE NING
Regulation Number878.4460
Classification Product Code
KGO  
Date Received01/29/2002
Decision Date 04/03/2002
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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