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    FDA 510(k) FDA class 1 Substantially Equivalent 🇲🇾 Malaysia

    LA GLOVE BRAND COLORED LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE (PINK/ GREEN/ VIOLET)

    K Number: K093193 · Decision Jun 8, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    22
    Review Days
    238

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    Basic Information

    Device Name
    LA GLOVE BRAND COLORED LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE (PINK/ GREEN/ VIOLET)
    K Number
    K093193
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    La Glove (M) Sdn. Bhd.
    Date Received
    October 13, 2009
    Decision Date
    June 8, 2010
    Product Code
    LYY
    Advisory Committee
    General Hospital
    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
    LYY Latex Patient Examination Glove

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    Other Clearances by La Glove (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)
    K991950 LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDER-FREE)
    K991949 LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDERED)
    K990883 LAGLOVE BRAND BLUE COLOLRED NITRILE EXAMINATION GLOVE (POWDERED)
    Search all 22 clearances from La Glove (M) Sdn. Bhd. →