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510(k) Data Aggregation

    K Number
    K102097
    Device Name
    POWDER FREE VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT
    Date Cleared
    2010-11-17

    (113 days)

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

    SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT

    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 Hospital and Personal Use 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-5250-06e1.
    Ask a Question
    K Number
    K102093
    Device Name
    POWDER FREE VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT
    Date Cleared
    2010-11-03

    (90 days)

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

    SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is disposable non-sterile 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 Hospital and Personal Use 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-5250-06e1.
    Ask a Question
    K Number
    K031108
    Device Name
    SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
    Manufacturer
    SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT
    Date Cleared
    2003-09-08

    (153 days)

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

    SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT

    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 D5250-00.
    Ask a Question
    K Number
    K021506
    Device Name
    POWDERED (BLUE) NITRILE PATIENT EXAMINATION GLOVES
    Manufacturer
    SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT
    Date Cleared
    2002-06-06

    (28 days)

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

    SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT

    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. Powdered Nitrile Patient Examination Glove, 80LZA, and meets all requirements of ASTM Standard D6319-00a1.
    Ask a Question
    K Number
    K014077
    Device Name
    POWDER FREE (BLUE) NITRILE PATIENT EXAMINATION GLOVES
    Manufacturer
    SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT
    Date Cleared
    2002-02-04

    (55 days)

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

    SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT

    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, 80LZA, and meets all requirements of ASTM Standard D6319-00a1.
    Ask a Question
    K Number
    K002012
    Device Name
    SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT
    Date Cleared
    2000-08-09

    (37 days)

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

    SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K002015
    Device Name
    SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT
    Date Cleared
    2000-08-09

    (37 days)

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

    SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K992554
    Device Name
    SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT
    Date Cleared
    2000-03-29

    (243 days)

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

    SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT

    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 800.6250. 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
    K Number
    K992862
    Device Name
    SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT
    Date Cleared
    1999-11-29

    (96 days)

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

    SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A glove 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, 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
    K Number
    K992555
    Device Name
    SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT
    Date Cleared
    1999-10-14

    (76 days)

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

    SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT

    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 800,6250, Powder-Free Vinvl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-92.
    Ask a Question

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