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510(k) Data Aggregation

    K Number
    K223102
    Device Name
    Tegamen Nitrile Examination Gloves
    Manufacturer
    M/S Tegamen Safety Products Private Limited
    Date Cleared
    2023-03-15

    (166 days)

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

    M/S Tegamen Safety Products Private Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Tegamen Nitrile Patient Examination gloves, is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner.
    Device Description
    The subject device in this 510(k) Notification is Tegamen Nitrile Examination Gloves, Powder Free. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
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