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510(k) Data Aggregation

    K Number
    K003350
    Device Name
    HEALTH-PLUS, SANITEX, RELIANCE MULTIPLY POWDER FREE POLYMER AND NITRILE COATED (BLUE)
    Manufacturer
    PAMITEX INDUSTRIES SDN BHD
    Date Cleared
    2001-04-05

    (161 days)

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

    PAMITEX INDUSTRIES SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000952
    Device Name
    HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATION GLOVES - BLUE COLOR
    Manufacturer
    PAMITEX INDUSTRIES SDN BHD
    Date Cleared
    2000-06-30

    (98 days)

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

    PAMITEX INDUSTRIES SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001674
    Device Name
    POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR
    Manufacturer
    PAMITEX INDUSTRIES SDN BHD
    Date Cleared
    2000-06-30

    (29 days)

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

    PAMITEX INDUSTRIES SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K001672
    Device Name
    POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES
    Manufacturer
    PAMITEX INDUSTRIES SDN BHD
    Date Cleared
    2000-06-23

    (22 days)

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

    PAMITEX INDUSTRIES SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K993756
    Device Name
    HEALTH-PLUS, SANITEX, RELIANCE STERILE POWDER-FREE NITRILE SURGICAL GLOVES
    Manufacturer
    PAMITEX INDUSTRIES SDN BHD
    Date Cleared
    2000-04-28

    (175 days)

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

    PAMITEX INDUSTRIES SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder-free nitrile surgeon's glove is a disposable device made of synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hands, usually in surgical setting to provide a barrier against potentially infectious materials and other contaminants.
    Device Description
    A powder-free nitrile surgeon's glove is a disposable device made of synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hands, usually in surgical setting to provide a barrier against potentially infectious materials and other contaminants.
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    K Number
    K000828
    Device Name
    HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATION GLOVE
    Manufacturer
    PAMITEX INDUSTRIES SDN BHD
    Date Cleared
    2000-04-07

    (24 days)

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

    PAMITEX INDUSTRIES SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K993201
    Device Name
    HEALTH-PLUS, SANITEX, RELIANCE POWEDER-FREE STERILE LATEX SURGICAL GLOVES
    Manufacturer
    PAMITEX INDUSTRIES SDN BHD
    Date Cleared
    2000-03-29

    (187 days)

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

    PAMITEX INDUSTRIES SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A sterile power-free latex surgeon's glove is a disposable device intended for medical purpose that is worn by operating room personnel to protect a surgical wound from contamination.
    Device Description
    Sterile Powder-Free Latex Surgical Gloves
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    K Number
    K993918
    Device Name
    HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVE (NATURAL RUBBER LATEX-NITRILE-CONSTRUCTION
    Manufacturer
    PAMITEX INDUSTRIES SDN BHD
    Date Cleared
    2000-02-10

    (84 days)

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

    PAMITEX 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 examiners.
    Device Description
    Multi-ply Powder-free Latex Examination Gloves with Protein content labeling claim(50ug/g or less total water extratable protein content)
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    K Number
    K993621
    Device Name
    HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MIC
    Manufacturer
    PAMITEX INDUSTRIES SDN BHD
    Date Cleared
    1999-12-29

    (64 days)

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

    PAMITEX INDUSTRIES SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is a disposable device intendedror for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiners.
    Device Description
    Pre-Powdered with USP Absorbable Dusting Powder Latex Examination Glove-Blue Color with Protein Labeling Claims 100mic grams or less)
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    K Number
    K993093
    Device Name
    HEALTH-PLUS, SANITEX, RELIANCE (50 MICROGRAMS)
    Manufacturer
    PAMITEX INDUSTRIES SDN BHD
    Date Cleared
    1999-10-29

    (43 days)

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

    PAMITEX INDUSTRIES 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 examiners.
    Device Description
    Powder-free Latex Examination Glove with Labeling Claim of 50 micrograms or less of total water extractable protein per gram.
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