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

    NON-CHLORINATED, POLYMER COATED POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES AND PROTEIN LABELING CLAIM OF

    K Number: K101645 · Decision Aug 26, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    10
    Review Days
    76

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    Basic Information

    Device Name
    NON-CHLORINATED, POLYMER COATED POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES AND PROTEIN LABELING CLAIM OF
    K Number
    K101645
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Latexx Manufacturing Sdn.Bhd.
    Date Received
    June 11, 2010
    Decision Date
    August 26, 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 Latexx Manufacturing Sdn.Bhd.

    K Number Device Name
    K102189 POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM
    K034052 BLACK COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES
    K022346 CLEANTEXX MINT FLAVOUR BLUE COLOUR POWDER-FREE BARRIER PRO COPOLYMER EXAMINATION GLOVES
    K022102 CLEANTEXX POWDERFREE BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVES, BLUE COLOUR
    K022548 MEDTEXX BLUE COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES
    K022347 MEDTEXX GREEN COLOUR POWDERED NITRILE RUBBER EXAMINATION GLOVES
    K022101 MEDTEXX POWDERFREE NITRILE RUBBER EXAMINATION GLOVES, GREEN COLOUR
    K014087 LATEXX MANUFACTURING NON-CHLORINATED, POLYMER COATED, POWDER-FREE RUBBER LATEX EXAMINATION GLOVE
    K013303 CLEANTEXX POWDERFREE SYNTHETIC LATEX EXAMINATION GLOVE MADE WITH BARRIER-PRO BUTADIENE CO-POLMER