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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 K904320
Device Name STERILE SURGEONS GLOVES (ULTRA-TOUCH-LATEX)
Applicant
R.K.F. Laboratories, Inc.
P.O. Box 880
Sabana Grande,  PR  00747
Applicant Contact ANGEL TORRES
Correspondent
R.K.F. Laboratories, Inc.
P.O. Box 880
Sabana Grande,  PR  00747
Correspondent Contact ANGEL TORRES
Regulation Number878.4460
Classification Product Code
KGO  
Date Received09/20/1990
Decision Date 11/07/1990
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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