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510(k) Data Aggregation

    K Number
    K994416
    Device Name
    POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
    Manufacturer
    FLEXITECH SDN. BHD.
    Date Cleared
    2000-02-03

    (36 days)

    Product Code
    LYYLZA
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    FLEXITECH SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Polymer Coated Powder Free Nitrile Examination Gloves, BLUE
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    K Number
    K994354
    Device Name
    POLYMER COATED, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
    Manufacturer
    FLEXITECH SDN. BHD.
    Date Cleared
    2000-01-31

    (39 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    FLEXITECH SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Polymer Coated, Powder Free, Latex Examination Gloves WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LES
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    K Number
    K990495
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVES
    Manufacturer
    FLEXITECH SDN. BHD.
    Date Cleared
    1999-04-02

    (44 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    FLEXITECH SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Powder Free Nitrile Examination Gloves. (Green and Blue)
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    K Number
    K990499
    Device Name
    PREPOWDERED NITRILE EXAMINATION GLOVES
    Manufacturer
    FLEXITECH SDN. BHD.
    Date Cleared
    1999-04-02

    (44 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    FLEXITECH SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Pre-Powdered Nitrile Examination Gloves
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    K Number
    K990501
    Device Name
    POWDER FREE LATEX EXAMINATION GLOVES, W/ PROTEIN LABELING CLAIM
    Manufacturer
    FLEXITECH SDN. BHD.
    Date Cleared
    1999-04-02

    (44 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    FLEXITECH SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Powder Free Latex Examination Gloves, with protein labeling claim (50 micrograms or less)
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    K Number
    K990502
    Device Name
    PREPOWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)
    Manufacturer
    FLEXITECH SDN. BHD.
    Date Cleared
    1999-04-02

    (44 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    FLEXITECH SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    PrePowdered Latex Examination Gloves with Protein claim.
    Ask a Question

    Ask a specific question about this device

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