FDA 510(k) Applications for Medical Device Product Code "FMC"
(Patient Examination Glove)

FDA 510(k) Number Applicant Device Name Decision Date
K042618 LAGLOVE (M) SDN. BHD. LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR) 11/26/2004
K992337 MEXPO INTL., INC. BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA 08/17/1999
K014134 SUPERGRADE HEALTHCARE PRODUCTS SDN. BHD. POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G) 01/22/2002


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