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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
    K230217
    Device Name
    Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs
    Manufacturer
    Grand Work Plastic Products Co., Ltd
    Date Cleared
    2023-05-13

    (107 days)

    Product Code
    KGO, LZC
    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
    This 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 D6978-05(Reapproved 2019).
    Device Description
    Sterile Polyisoprene Powder Free Surgical Glove, tested for Use with Chemotherapy Drugs is a disposable singleuse, sterile, Cream-colored and powder-free surgical glove made from synthetic polyisoprene latex.
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    K Number
    K222892
    Device Name
    Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs
    Manufacturer
    Grand Work Plastic Products Co., Ltd
    Date Cleared
    2022-12-15

    (83 days)

    Product Code
    LZA, LZC, OPJ
    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 a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05(2019)
    Device Description
    Powder Free Polyurethane Examination Gloves, Blue color, tested for use with Chemotherapy Drugs are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of nitrile rubber materials and are powder free. They are ambidextrous and come in different sizes-XS, S, M, L, XL and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05(2019).
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    K Number
    K213574
    Device Name
    Nitrile Vinyl Blend Powder Free Examination Gloves (Black)
    Manufacturer
    Grand Work Plastic Products Co., Ltd
    Date Cleared
    2022-07-12

    (244 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
    Nitrile Vinyl Blend Powder Free Examination Gloves (Black) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Nitrile Vinvl Blend Powder Free Examination Gloves (Black) 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. They are ambidextrous and come in different sizes-XS, S, M, L and XL. The physical and performance characteristics of the devices meet all requirements of ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
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    K Number
    K220249
    Device Name
    Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue)
    Manufacturer
    Grand Work Plastic Products Co., Ltd
    Date Cleared
    2022-05-26

    (115 days)

    Product Code
    LZA, LZC, 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
    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. In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978 standards. Gloves is direct contact and not to be worn for more than 24 hours.
    Device Description
    The subject device is Sterile Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs And Fentanyl Citrate (Blue). The subject device is a patient examination glove made from nitrile latex compound, blue color, powder free and sterile (Per 21 CFR 880.6250, class I). The device is direct contact and not to be worn for more than 24 hours. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility per 10993-11 and permeability to chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05(2019).
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    K Number
    K220250
    Device Name
    Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
    Manufacturer
    Grand Work Plastic Products Co., Ltd
    Date Cleared
    2022-05-11

    (100 days)

    Product Code
    LZA, LZC
    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
    Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs 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. In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978 standards.
    Device Description
    The subject device is Nitrile Examination Gloves Sterile with Chemotherapy drugs claims. The subject device is a patient examination glove made from nitrile latex compound, blue color, powder free and sterile (Per 21 CFR 880.6250, class I). The device is direct contact and not to be worn for more than 24 hours. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility per 10993-10, 10993-11 and permeability to chemotherapy drugs per ASTM D6978-05(2019).
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    K Number
    K220240
    Device Name
    Vinyl Co-Polymer Powder-free Examination Gloves, Black
    Manufacturer
    Grand Work Plastic Products Co., Ltd
    Date Cleared
    2022-03-31

    (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
    Vinyl Co-Polymer Powder-free Examination Gloves, Black is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Vinyl Co-Polymer Powder-free Examination Gloves, Black 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 D5250-19 Standard Specification for Vinyl Examination Gloves for Medical Application.
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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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