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510(k) Data Aggregation

    K Number
    K093335
    Device Name
    LAGLOVE BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE (PINK COLOR)
    Manufacturer
    LAGLOVE (M) SDN. BHD.
    Date Cleared
    2010-06-18

    (235 days)

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

    LAGLOVE (M) SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Laglove TM Brand Nitrile Examination Gloves, Powder Free, Non - Sterile (Pink Color) is a patient examination glove is a disposable device intended for medical purpose worn on the examiners hand or finger to prevent contamination between patient and examiner.
    Device Description
    Laglove ™ Brand Nitrile Examination Gloves, Powder Free, Non-Sterile. (Pink Color)
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    K Number
    K092498
    Device Name
    LAGLOVE BRAND NITRILE EXAMINATION GLOVES POWDERED, NON STERILE (PINK COLOR)
    Manufacturer
    LAGLOVE (M) SDN. BHD.
    Date Cleared
    2009-11-20

    (98 days)

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

    LAGLOVE (M) SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Laglove TM Brand Nitrile Examination Gloves, Powdered, Non - Sterile (Pink Color) is a patient examination glove is a disposable device intended for medical purpose worn on the examiners hand or finger to prevent contamination between patient and examiner.
    Device Description
    Laglove TM Brand Nitrile Examination Gloves, Powdered, Non-Sterile. (Pink Color)
    Ask a Question
    K Number
    K092499
    Device Name
    LAGLOVE BRAND COLORED LATEX EXAMINATION GLOVES POWDERED, NON-STERILE (PINK/GREEN/VIOLET)
    Manufacturer
    LAGLOVE (M) SDN. BHD.
    Date Cleared
    2009-11-20

    (98 days)

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

    LAGLOVE (M) SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Laglove TM Brand Latex Examination Gloves, Powdered, Non - Sterile (Pink, Green, Violet) is a patient examination glove is a disposable device intended for medical purpose worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Laglove ™ Brand Latex Examination Gloves, Powdered, Non-Sterile. (Pink, Green, Violet)
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    K Number
    K042618
    Device Name
    LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR)
    Manufacturer
    LAGLOVE (M) SDN. BHD.
    Date Cleared
    2004-11-26

    (60 days)

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

    LAGLOVE (M) SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LaGlove™ Brand Double Polymer Coated Nitrile Examination Gloves (Powder Free - Blue Color) is a disposable patient examination glove which is worn on the hand of a healthcare and similar personnel to prevent contamination between patient and examiner.
    Device Description
    LaGlove™ Brand Double Polymer Coated Nitrile Examination Gloves (Powder Free - Blue Color)
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    K Number
    K010863
    Device Name
    LAGLOVE BRAND NITROPRENE POWDER FREE EXAMINATION GLOVES (MADE OF NITRILE-NEOPRENE CO-POLYMER)
    Manufacturer
    LAGLOVE (M) SDN. BHD.
    Date Cleared
    2001-05-03

    (42 days)

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

    LAGLOVE (M) SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K010860
    Device Name
    LAGLOVE BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (GREEN/PURPLE)
    Manufacturer
    LAGLOVE (M) SDN. BHD.
    Date Cleared
    2001-04-03

    (12 days)

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

    LAGLOVE (M) SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K010861
    Device Name
    LAGLOVE BRAND COLORED POWDERED NITRILE EXAMINATION GLOVES(GREEN/PURPLE)
    Manufacturer
    LAGLOVE (M) SDN. BHD.
    Date Cleared
    2001-04-03

    (12 days)

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

    LAGLOVE (M) SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K991949
    Device Name
    LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDERED)
    Manufacturer
    LAGLOVE (M) SDN. BHD.
    Date Cleared
    1999-08-12

    (64 days)

    Product Code
    KGO, DAT
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    LAGLOVE (M) SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LAGLOVE™ Brand Nitrile Surgical Gloves -Sterile (Powdered) is a disposable glove made of synthetic rubber intended to be worn by operating room personnel to provide a barrier against potentially infectious materials and other contaminants.
    Device Description
    LAGLOVE™ Brand Nitrile Surgical Gloves -Sterile (Powdered) is a disposable glove made of synthetic rubber.
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    K Number
    K991950
    Device Name
    LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDER-FREE)
    Manufacturer
    LAGLOVE (M) SDN. BHD.
    Date Cleared
    1999-08-12

    (64 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    LAGLOVE (M) SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LAGLOVE™ Brand Nitrile Surgical Gloves -Sterile (Powder-Free) is a disposable glove made of synthetic rubber intended to be worn by operating personnel during surgical procedures to help prevent contamination between health-care personnel and the patient.
    Device Description
    disposable glove made of synthetic rubber
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    K Number
    K990883
    Device Name
    LAGLOVE BRAND BLUE COLOLRED NITRILE EXAMINATION GLOVE (POWDERED)
    Manufacturer
    LAGLOVE (M) SDN. BHD.
    Date Cleared
    1999-08-10

    (147 days)

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

    LAGLOVE (M) SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Laglove™ Brand, Colored Nitrile Examination Glove (Powdered) is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.
    Device Description
    Laglove™ Brand Colored Nitrile (Blue) Examination Gloves (Powdered)
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