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510(k) Data Aggregation

    K Number
    K031293
    Device Name
    SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
    Manufacturer
    SHIJIAZHUANG EVERSHARP PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    2003-05-09

    (16 days)

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

    SHIJIAZHUANG EVERSHARP 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.
    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.
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    K Number
    K011883
    Device Name
    POWDERED SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    SHIJIAZHUANG EVERSHARP PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    2001-07-17

    (29 days)

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

    SHIJIAZHUANG EVERSHARP 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 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 D5250-00.
    Ask a Question
    K Number
    K011884
    Device Name
    POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    SHIJIAZHUANG EVERSHARP PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    2001-07-17

    (29 days)

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

    SHIJIAZHUANG EVERSHARP 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 10 ween 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 D5250-00.
    Ask a Question
    K Number
    K011885
    Device Name
    SYNTHETIC POWDER FREE VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    SHIJIAZHUANG EVERSHARP PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    2001-07-16

    (28 days)

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

    SHIJIAZHUANG EVERSHARP 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 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, 80L YZ, and meets all requirements of ASTM Standard D5250-00.
    Ask a Question
    K Number
    K011882
    Device Name
    SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    SHIJIAZHUANG EVERSHARP PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    2001-07-10

    (22 days)

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

    SHIJIAZHUANG EVERSHARP 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.
    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 requirement of ASTM Standard D5250-00.
    Ask a Question

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