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510(k) Data Aggregation

    K Number
    K232444
    Device Name
    Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs
    Manufacturer
    Grand Work Plastic Products Co., Ltd.
    Date Cleared
    2023-12-20

    (128 days)

    Product Code
    KGO, LZC, OPJ
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    Grand Work Plastic Products Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978.
    Device Description
    Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs is a disposable single-use, sterile, natural-colored and powder-free surgical glove made from rubber latex. They are in different sizes - 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0. Gloves meet the specification of ASTM D3577-19 and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05(2019).
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    K Number
    K232039
    Device Name
    Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
    Manufacturer
    Grand Work Plastic Products Co., Ltd.
    Date Cleared
    2023-08-09

    (30 days)

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

    Grand Work Plastic Products Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 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. In addition, these gloves were tested for use with Chemotherapy drugs and fentanyl citrate in accordance with ASTM D6978.
    Device Description
    The subject device is Nitrile Examination Gloves Sterile with Chemotherapy drugs and fentanyl citrate claims. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and sterile. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for permeability to chemotherapy drugs and fentanyl citrate per ASTM D6978-05(2019).
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    K Number
    K142409
    Device Name
    Vinyl Co-Polymer Powder Free Examination Gloves
    Manufacturer
    GRAND WORK PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    2014-12-05

    (100 days)

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

    GRAND WORK 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
    Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl and oil-based liquid nitrile rubber 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
    K102089
    Device Name
    GRAND WORK PLASTIC PRODUCTS CO., LTD. POWDER FREE VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    GRAND WORK PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    2010-10-06

    (62 days)

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

    GRAND WORK 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 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.
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    K Number
    K102094
    Device Name
    POWDER FREE VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    GRAND WORK PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    2010-10-05

    (61 days)

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

    GRAND WORK 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 Hospital and Personal Use Device panel as Class I, 21 CFR §880.6250 Patient Examination Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.
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    K Number
    K061562
    Device Name
    VINYL CO-POLYMER POWDER FREE EXAMINATION GLOVES, BLUE COLOR
    Manufacturer
    GRAND WORK PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    2006-07-11

    (36 days)

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

    GRAND WORK 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 Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4
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    K Number
    K051662
    Device Name
    VINYL NITRILE CO-POLYMER POWDER FREE EXAM GLOVES (BLUE COLOR)
    Manufacturer
    GRAND WORK PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    2005-07-22

    (30 days)

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

    GRAND WORK 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. The Vinyl Plastic Co-Polymer Powder-Free Examination Gloves (Blue Color) is a disposable device intended for medical purposes that is worn on the examiner's hands 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 Glove, 80 LZA, and meets all requirements of ASTM standard D-6319-00a1 and ASTM D-5250.
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    K Number
    K042830
    Device Name
    POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES
    Manufacturer
    GRAND WORK PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    2004-11-17

    (35 days)

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

    GRAND WORK 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, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-00€4.
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    K Number
    K040682
    Device Name
    SYNTHETIC VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
    Manufacturer
    GRAND WORK PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    2004-07-28

    (134 days)

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

    GRAND WORK 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 hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250)
    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
    K041225
    Device Name
    SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES-POWERED
    Manufacturer
    GRAND WORK PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    2004-07-15

    (66 days)

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

    GRAND WORK 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, Powdered Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-00E4.
    Ask a Question

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