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510(k) Data Aggregation

    K Number
    K142570
    Device Name
    Powder Free Vinyl Patient Examination Gloves ( Yellow, White, BLue, Pink )
    Manufacturer
    EVER LIGHT PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    2014-12-18

    (97 days)

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

    EVER LIGHT PLASTIC PRODUCTS CO., LTD.

    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
    Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink) are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-06 (Reapproved 2011) Standard Specification For Poly(Vinyl Chloride) Gloves For Medical Application.
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    K Number
    K142571
    Device Name
    Powder Free Vinyl Patient Examination Gloves
    Manufacturer
    EVER LIGHT PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    2014-12-17

    (96 days)

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

    EVER LIGHT PLASTIC PRODUCTS CO., LTD.

    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
    Powder Free Vinyl Patient Examination Gloves are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-06 (Reapproved 2011) Standard Specification For Poly(Vinyl Chloride) Gloves For Medical Application.
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    K Number
    K102655
    Device Name
    POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA (YELLOW, WHITE, BLUE)
    Manufacturer
    EVER LIGHT PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    2010-10-29

    (44 days)

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

    EVER LIGHT PLASTIC PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K082029
    Device Name
    SYNTHETIC POWDER FREE (PINK) VINYL PATIENT EXAMINATION GLOVE
    Manufacturer
    EVER LIGHT PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    2008-09-26

    (71 days)

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

    EVER LIGHT 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, 80 LYZ, and meets all requirements of ASTM standard D-5250-06.
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    K Number
    K063214
    Device Name
    EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    EVER LIGHT PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    2006-12-08

    (46 days)

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

    EVER LIGHT 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 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, Powered Vinyl Patient Examination Gloves, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4.
    Ask a Question
    K Number
    K063215
    Device Name
    EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    EVER LIGHT PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    2006-12-08

    (46 days)

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

    EVER LIGHT 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 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, Powered Vinyl Patient Examination Gloves, 80 L YZ, and meets all requirements of ASTM standard D-5250-00E4.
    Ask a Question
    K Number
    K063213
    Device Name
    EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    EVER LIGHT PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    2006-12-05

    (43 days)

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

    EVER LIGHT 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 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, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4.
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    K Number
    K060785
    Device Name
    POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES W/ALOE VERA, GREEN COLOR
    Manufacturer
    EVER LIGHT PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    2006-07-07

    (107 days)

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

    EVER LIGHT 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 contamingtion 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 Synthetic Examination Gloves with Aloe Vert Creen Color, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4.
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    K Number
    K060786
    Device Name
    SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVE-POWDER FREE
    Manufacturer
    EVER LIGHT PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    2006-05-08

    (47 days)

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

    EVER LIGHT 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 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, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4.
    Ask a Question
    K Number
    K060784
    Device Name
    SYNTHETIC VINYL PATIENT EXAMINATION GLOVE-POWERED
    Manufacturer
    EVER LIGHT PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    2006-05-01

    (40 days)

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

    EVER LIGHT 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 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, Powered Vinyl Patient Examination Gloves. 80 LYZ. and meets all requirements of ASTM standard D-5250-00E4.
    Ask a Question

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