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510(k) Data Aggregation

    K Number
    K232550
    Device Name
    Nitrile Examination Gloves, Dual Color Black-Blue
    Manufacturer
    Shanxi Hongjin Plastic Technology Co., Ltd.
    Date Cleared
    2023-10-20

    (58 days)

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

    Shanxi Hongjin Plastic Technology 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.
    Device Description
    Nitrile Examination Gloves, Dual Color Black-Blue are Class I Patient Examination Gloves. The glove is made dual color by double dipping. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19. The gloves are single use, disposable, and provided non-sterile.
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    K Number
    K232353
    Device Name
    Powder Free Nitrile Examination Gloves (Black)
    Manufacturer
    Shanxi Hongjin Plastic Technology Co., Ltd.
    Date Cleared
    2023-08-31

    (24 days)

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

    Shanxi Hongjin Plastic Technology 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.
    Device Description
    The subject device is a patient examination glove made from nitrile latex compound, powder free and non-sterile (Per 21 CFR 880.6250, class I). They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves.
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    K Number
    K230779
    Device Name
    Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
    Manufacturer
    Shanxi Hongjin Plastic Technology Co., Ltd.
    Date Cleared
    2023-06-09

    (80 days)

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

    Shanxi Hongjin Plastic Technology 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 and Fentanyl Citrate using ASTM D6978-05(2019)
    Device Description
    Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.
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    K Number
    K220229
    Device Name
    Powder Free Nitrile Examination Gloves, Orange
    Manufacturer
    Shanxi Hongjin Plastic Technology Co., Ltd.
    Date Cleared
    2022-03-26

    (58 days)

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

    Shanxi Hongjin Plastic Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Powder Free Nitrile Examination Gloves, Orange 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
    Powder Free Nitrile Examination Gloves, Orange are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of nitrile latex and are powder free. They are ambidextrous. 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
    K211604
    Device Name
    Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
    Manufacturer
    Shanxi Hongjin Plastic Technology Co., Ltd.
    Date Cleared
    2021-10-27

    (155 days)

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

    Shanxi Hongjin Plastic Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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 to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs using ASTM D6978 and will be labeled with a statement of compliance and a summary of the testing results.
    Device Description
    Powder Free Nitrile Examination Gloves(Blue), Tested for Use with Chemotherapy Drugs are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes-Extra Small, Small, Medium, Large and Extra Large. 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).
    Ask a Question

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