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510(k) Data Aggregation

    K Number
    K053521
    Device Name
    PRE-POWDERED STERILE VINYL GLOVE, CLEAR
    Manufacturer
    SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO., LTD
    Date Cleared
    2006-03-29

    (100 days)

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

    SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO

    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 hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment. A patient examination glove is 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
    Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powdered vinyl Patient Examination Glove, 80LYZ, Powdered with Absorbable Dusting Powder, USP, and meets all requirements of ASTM Standard D5250-00-4.
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    K Number
    K053523
    Device Name
    POWDER FREE STERILE VINYL GLOVE (CLEAR AND YELLOW)
    Manufacturer
    SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO., LTD
    Date Cleared
    2006-02-14

    (57 days)

    Product Code
    LYZ, 80L
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO

    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 hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment. 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 Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D-5250-00-4.
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    K Number
    K042247
    Device Name
    SYNTHETIC (BLUE) VINYL PATIENT EXAMINATION GLOVES - POWDER FREE
    Manufacturer
    SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO., LTD
    Date Cleared
    2004-09-02

    (14 days)

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

    SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO

    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
    Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80L YZ, and meets all requirements of ASTM Standard D5250-00E4
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    K Number
    K001861
    Device Name
    SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO; LTD.
    Date Cleared
    2000-07-11

    (22 days)

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

    SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO; LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K001863
    Device Name
    SYNTHETIC POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO; LTD.
    Date Cleared
    2000-07-11

    (22 days)

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

    SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO; LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K001834
    Device Name
    SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO; LTD.
    Date Cleared
    2000-06-30

    (14 days)

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

    SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO; LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K001862
    Device Name
    SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO; LTD.
    Date Cleared
    2000-06-30

    (11 days)

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

    SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO; LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K992821
    Device Name
    SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO., LTD
    Date Cleared
    2000-03-10

    (203 days)

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

    SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO

    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 hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
    Device Description
    Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-92.
    Ask a Question
    K Number
    K992797
    Device Name
    SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO., LTD
    Date Cleared
    1999-11-05

    (78 days)

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

    SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO

    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 hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment. A patient examination glove is 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
    Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powdered Vinyl Patient Examination Glove, 80LYZ, Powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.
    Ask a Question

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