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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 K896327
Device Name SURGEON'S GLOVES
Applicant
Productes Del Latex, S.A.
60 Cutter Mill Rd.
Suite 514
Great Neck,  NY  11021
Applicant Contact LEO R MINDICK
Correspondent
Productes Del Latex, S.A.
60 Cutter Mill Rd.
Suite 514
Great Neck,  NY  11021
Correspondent Contact LEO R MINDICK
Regulation Number878.4460
Classification Product Code
KGO  
Date Received11/02/1989
Decision Date 11/08/1989
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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