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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 K932061
Device Name MIRACLE GLOVE UNDER THE GLOVE GLOVING CREAM
Applicant
Advanced Chemical Technology, Inc.
309 E. Maxwell
P.O. Box 1748
Lakeland,  FL  33802
Applicant Contact ROY FISHER
Correspondent
Advanced Chemical Technology, Inc.
309 E. Maxwell
P.O. Box 1748
Lakeland,  FL  33802
Correspondent Contact ROY FISHER
Regulation Number878.4460
Classification Product Code
KGO  
Date Received04/28/1993
Decision Date 11/16/1993
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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