BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇲🇬 Madagascar

    LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDER-FREE)

    K Number: K991950 · Decision Aug 12, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    556
    Applicant Total
    21
    Review Days
    64

    Basic Information

    Device Name
    LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDER-FREE)
    K Number
    K991950
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    LAGLOVE (M) SDN. BHD.
    Date Received
    June 9, 1999
    Decision Date
    August 12, 1999
    Product Code
    KGO
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KGO Surgeon'S Gloves

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    Other Clearances by LAGLOVE (M) SDN. BHD.

    K Number Device Name
    K093335 LAGLOVE BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE (PINK COLOR)
    K092499 LAGLOVE BRAND COLORED LATEX EXAMINATION GLOVES POWDERED, NON-STERILE (PINK/GREEN/VIOLET)
    K092498 LAGLOVE BRAND NITRILE EXAMINATION GLOVES POWDERED, NON STERILE (PINK COLOR)
    K042618 LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR)
    K010863 LAGLOVE BRAND NITROPRENE POWDER FREE EXAMINATION GLOVES (MADE OF NITRILE-NEOPRENE CO-POLYMER)
    K010860 LAGLOVE BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (GREEN/PURPLE)
    K010861 LAGLOVE BRAND COLORED POWDERED NITRILE EXAMINATION GLOVES(GREEN/PURPLE)
    K991949 LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDERED)
    K990883 LAGLOVE BRAND BLUE COLOLRED NITRILE EXAMINATION GLOVE (POWDERED)
    K992019 LAGLOVE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
    Search all 21 clearances from LAGLOVE (M) SDN. BHD. →