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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 K901398
Device Name LATEX SURGEON GLOVES
Applicant
Sinochem (Usa), Inc.
P.O. Box 162
Baptistown,  NJ  08803
Applicant Contact LYNETTE HOWARD
Correspondent
Sinochem (Usa), Inc.
P.O. Box 162
Baptistown,  NJ  08803
Correspondent Contact LYNETTE HOWARD
Regulation Number878.4460
Classification Product Code
KGO  
Date Received03/26/1990
Decision Date 05/16/1990
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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