FDA 510(k) Applications Submitted by ELLEN HUTAPEA

FDA 510(k) Number Submission Date Device Name Applicant
K010232 01/24/2001 PRE-POWDERED NITRILE EXAMINATION GLOVES P.T. HEALTHCARE GLOVINDO
K010233 01/24/2001 POWDER FREE NITRILE EXAMINATION GLOVES P.T. HEALTHCARE GLOVINDO
K980605 02/17/1998 LOW PROTEIN LATEX PATIENT EXAMINATION GLOVES (POWDER-FREE) PT. SARANA INDOPROTEX
K000838 03/14/2000 DIGITCARE POWDER FREE COATED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) P.T. HEALTHCARE GLOVINDO
K021659 05/20/2002 PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (180 UG/OR LESS) P.T. HEALTHCARE GLOVINDO
K974853 12/29/1997 LATEX (POWDER FREE) LOW PROTEIN P.T. HEALTHCARE GLOVINDO


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