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510(k) Data Aggregation

    K Number
    K994082
    Device Name
    POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) (50 MICROGRAM OR LESS)
    Manufacturer
    BESGLOVE MEDICARE SDN. BHD.
    Date Cleared
    2000-01-28

    (56 days)

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

    BESGLOVE MEDICARE SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to pervent contamination between patient and examiner.
    Device Description
    Powdered Latex Examination Gloves (Protein Label Claim) (50 microgram or less)
    Ask a Question
    K Number
    K993500
    Device Name
    POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL OF 50 MCROGRAM OR LESS)
    Manufacturer
    BESGLOVE MEDICARE SDN. BHD.
    Date Cleared
    1999-12-02

    (48 days)

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

    BESGLOVE MEDICARE SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to pervent contamination between patient and examiner.
    Device Description
    Powderfree Latex Examination Gloves (Polymer Coated) (Protein Label Claim) 50 MICROGRAMS OR LESS
    Ask a Question
    K Number
    K993495
    Device Name
    POWDERED LATEX EXAMINATION GLOVES(PROTEIN LABEL CLAIM 150 MICROGRAMS OR LESS)
    Manufacturer
    BESGLOVE MEDICARE SDN. BHD.
    Date Cleared
    1999-11-24

    (40 days)

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

    BESGLOVE MEDICARE SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to pervent contamination between patient and examiner.
    Device Description
    Powdered Latex Examination Gloves (Protein Label Claim) (150 MICROGRAMS OR LESS)
    Ask a Question
    K Number
    K993502
    Device Name
    POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM 50 MICROGRAMS OR LESS)
    Manufacturer
    BESGLOVE MEDICARE SDN. BHD.
    Date Cleared
    1999-11-24

    (40 days)

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

    BESGLOVE MEDICARE SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Powderfree Latex Examination Gloves (Protein Label Claim) 50 MICROGRAMS OR LESS
    Ask a Question
    K Number
    K981877
    Device Name
    NITRILE POWDERFREE EXAMINATION GLOVES
    Manufacturer
    BESGLOVE MEDICARE SDN. BHD.
    Date Cleared
    1998-08-11

    (75 days)

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

    BESGLOVE MEDICARE SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or prevent contamination between patient and finger to examiner.
    Device Description
    Nitrile Powder-Free Examination Gloves
    Ask a Question
    K Number
    K981878
    Device Name
    POWDERFREE NITRILE EXAMINATION GLOVES (POLYMER COATED)
    Manufacturer
    BESGLOVE MEDICARE SDN. BHD.
    Date Cleared
    1998-08-11

    (75 days)

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

    BESGLOVE MEDICARE SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Powder-Free Nitrile Examination Gloves (Polymer Coated)
    Ask a Question
    K Number
    K981879
    Device Name
    POWDERED NITRILE EXAMINATION GLOVES
    Manufacturer
    BESGLOVE MEDICARE SDN. BHD.
    Date Cleared
    1998-08-11

    (75 days)

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

    BESGLOVE MEDICARE SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or prevent contamination between patient and finger to examiner.
    Device Description
    Powdered Nitrile Examination Gloves
    Ask a Question
    K Number
    K982286
    Device Name
    POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED)
    Manufacturer
    BESGLOVE MEDICARE SDN. BHD.
    Date Cleared
    1998-08-11

    (42 days)

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

    BESGLOVE MEDICARE SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Powdered Green Latex Examination Gloves (Polymer Coated)
    Ask a Question
    K Number
    K982284
    Device Name
    POWDERED GREEN LATEX EXAMINATION GLOVES
    Manufacturer
    BESGLOVE MEDICARE SDN. BHD.
    Date Cleared
    1998-08-03

    (34 days)

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

    BESGLOVE MEDICARE SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or contamination between patient and finger to prevent examiner.
    Device Description
    Powdered Green Latex Examination Gloves
    Ask a Question
    K Number
    K982285
    Device Name
    POWDERFREE GREEN LATEX EXAMINATION GLOVES
    Manufacturer
    BESGLOVE MEDICARE SDN. BHD.
    Date Cleared
    1998-08-03

    (34 days)

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

    BESGLOVE MEDICARE SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Powderfree Green Latex Examination Gloves
    Ask a Question

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