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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 K890073
Device Name MODERN LATEX STERILE SURGICAL GLOVES
Applicant
Modern Rubber Co., Ltd. C/O World Trade Svc.
720 N. Post Oak
Suite 230
Houston,  TX  77024
Applicant Contact JOE VICK
Correspondent
Modern Rubber Co., Ltd. C/O World Trade Svc.
720 N. Post Oak
Suite 230
Houston,  TX  77024
Correspondent Contact JOE VICK
Regulation Number878.4460
Classification Product Code
KGO  
Date Received01/09/1989
Decision Date 01/24/1989
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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