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510(k) Data Aggregation

    K Number
    K210145
    Device Name
    Nitrile Glove Powder Free Blue
    Manufacturer
    Changzhou Universal Medical Equipment CO. LTD.
    Date Cleared
    2021-04-21

    (90 days)

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

    Changzhou Universal Medical Equipment CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nitrile Glove Powder Free Blue 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 proposed device is powder free, non-sterile nitrile examination gloves. Following FDA Code LZA, a "nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants."
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