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510(k) Data Aggregation

    K Number
    K223004
    Device Name
    Disposable Nitrile Examination Gloves
    Manufacturer
    Jiangxi Handspro Products Solutions CO., LTD.
    Date Cleared
    2022-12-04

    (66 days)

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

    Jiangxi Handspro Products Solutions CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Nitrile Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
    Device Description
    The subject device is powder free nitrile examination gloves. The subject device is in blue color. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
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    K Number
    K223008
    Device Name
    Disposable Vinyl Examination Gloves
    Manufacturer
    Jiangxi Handspro Products Solutions CO., LTD.
    Date Cleared
    2022-10-08

    (9 days)

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

    Jiangxi Handspro Products Solutions CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Vinyl Examination Glove 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
    The subject device is powder free non-colored vinyl examination glove. It can be available in four specifications: S, M, L and XL. The subject device is non-sterile.
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