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510(k) Data Aggregation

    K Number
    K011895
    Device Name
    POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES, POLYMER COATED ON OUTSIDE AND NITRILE COATED ON INSIDE, BLUE COLOR WITH
    Manufacturer
    PWA INDUSTRIES SDN. BHD.
    Date Cleared
    2001-07-09

    (21 days)

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

    PWA INDUSTRIES SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Powder-free Multi-ply Latex Examination Gloves, Polymer Coated on the Outside and Nitrile Coated on the Inside (Blue Color). With Protein Labeling claim 50ug/g or less of total extractable protein content.
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    K Number
    K010077
    Device Name
    HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVES
    Manufacturer
    PWA INDUSTRIES SDN. BHD.
    Date Cleared
    2001-02-28

    (49 days)

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

    PWA INDUSTRIES SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K001475
    Device Name
    HEALTH-PLUS, SANITEX, RELIANCE, POWDERED LATEX EXAM GLOVES CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PR
    Manufacturer
    PWA INDUSTRIES SDN. BHD.
    Date Cleared
    2000-06-13

    (33 days)

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

    PWA INDUSTRIES SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K001485
    Device Name
    HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE LATEX EXAMINATION GLOVES
    Manufacturer
    PWA INDUSTRIES SDN. BHD.
    Date Cleared
    2000-06-13

    (32 days)

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

    PWA INDUSTRIES SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K981774
    Device Name
    MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
    Manufacturer
    PWA INDUSTRIES SDN. BHD.
    Date Cleared
    1998-07-24

    (65 days)

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

    PWA INDUSTRIES SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Prepowdered Latex Examination Glove - Blue color
    Ask a Question
    K Number
    K973913
    Device Name
    MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
    Manufacturer
    PWA INDUSTRIES SDN. BHD.
    Date Cleared
    1997-12-18

    (65 days)

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

    PWA INDUSTRIES SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For examination purposes for personnel and similar personnel to prevent contamination between health care worker and the patient's body, fluids and waste.
    Device Description
    Powder-Free Latex Examination Glove (Polymer-Coated)
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    K Number
    K973551
    Device Name
    MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
    Manufacturer
    PWA INDUSTRIES SDN. BHD.
    Date Cleared
    1997-11-06

    (48 days)

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

    PWA INDUSTRIES SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Powderfree, Blue Nitrile Examination Glove
    Ask a Question
    K Number
    K972169
    Device Name
    MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
    Manufacturer
    PWA INDUSTRIES SDN. BHD.
    Date Cleared
    1997-10-03

    (116 days)

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

    PWA INDUSTRIES SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Patient Examination Device
    Device Description
    Not Found
    Ask a Question
    K Number
    K964724
    Device Name
    POWDER-FREE LATEX EXAMINATION GLOVES
    Manufacturer
    PWA INDUSTRIES SDN. BHD.
    Date Cleared
    1997-06-16

    (213 days)

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

    PWA INDUSTRIES SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Not Found
    Ask a Question
    K Number
    K963560
    Device Name
    MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
    Manufacturer
    PWA INDUSTRIES SDN. BHD.
    Date Cleared
    1996-10-24

    (49 days)

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

    PWA INDUSTRIES SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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