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510(k) Data Aggregation

    K Number
    K092302
    Device Name
    POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA, GREEN COLOR
    Manufacturer
    BETTERCARE PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    2010-05-05

    (280 days)

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

    BETTERCARE PLASTIC PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is disposable device intended for medical a purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.
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    K Number
    K092301
    Device Name
    POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (YELLOW, WHITE, BLUE, PINK)
    Manufacturer
    BETTERCARE PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    2009-10-22

    (85 days)

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

    BETTERCARE PLASTIC PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is 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
    Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power Free Vinyl Patient Examination Gloves, (Yellow, white, blue, pink), 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.
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    K Number
    K092294
    Device Name
    VINYL CO-POLMER FREE EXAMINATION GLOVES, BLUE COLOR
    Manufacturer
    BETTERCARE PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    2009-10-21

    (84 days)

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

    BETTERCARE PLASTIC PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is 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
    Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.
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    K Number
    K092296
    Device Name
    POWDER FREE EXAMINATION GLOVE
    Manufacturer
    BETTERCARE PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    2009-10-21

    (84 days)

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

    BETTERCARE PLASTIC PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is 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
    Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power Free Vinyl Patient Examination Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-06el.
    Ask a Question

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