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510(k) Data Aggregation

    K Number
    K000071
    Device Name
    SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    SHIJIAZHUANG GREAT EAGLE PLASTIC PRODUCTS CO., LTD
    Date Cleared
    2000-02-29

    (50 days)

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

    SHIJIAZHUANG GREAT EAGLE PLASTIC PRODUCTS CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K000166
    Device Name
    SYNTHETIC (WHITE) VINAL POWDERED PATIENT EXAMINATION GLOVES
    Manufacturer
    SHIJIAZHUANG GREAT EAGLE PLASTIC PRODUCTS CO., LTD
    Date Cleared
    2000-02-22

    (34 days)

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

    SHIJIAZHUANG GREAT EAGLE PLASTIC PRODUCTS CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K992861
    Device Name
    SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    SHIJIAZHUANG GREAT EAGLE PLASTIC PRODUCTS CO., LTD
    Date Cleared
    1999-10-06

    (42 days)

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

    SHIJIAZHUANG GREAT EAGLE PLASTIC PRODUCTS CO., LTD

    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 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 (yellow) Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-92.
    Ask a Question
    K Number
    K983645
    Device Name
    SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    SHIJIAZHUANG GREAT EAGLE PLASTIC PRODUCTS CO., LTD
    Date Cleared
    1998-12-04

    (49 days)

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

    SHIJIAZHUANG GREAT EAGLE PLASTIC PRODUCTS CO., LTD

    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 similar personnel to prevent contamination between and healthcare personnel and the patient's body, fluids, waste or environment. 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 21 CFR 880.6250, Powdered Vinyl Patient Class I, as Examination Glove, 80LYZ, Powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.
    Ask a Question
    K Number
    K983207
    Device Name
    SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    SHIJIAZHUANG GREAT EAGLE PLASTIC PRODUCTS CO., LTD
    Date Cleared
    1998-10-30

    (46 days)

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

    SHIJIAZHUANG GREAT EAGLE PLASTIC PRODUCTS CO., LTD

    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 similar personnel to prevent contamination between and healthcare personnel and the patient's body, fluids, waste or environment. 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 Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient as Examination Glove, 80LYZ and meets all requirements of ASTM Standard D5250-92.
    Ask a Question

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