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510(k) Data Aggregation

    K Number
    K210730
    Device Name
    Nitrile Patient Examination Glove
    Date Cleared
    2021-08-10

    (152 days)

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

    American Performance Polymers, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A powder-free patient examination 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. These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
    Device Description
    The Nitrile Medical Examination Glove is a non-sterile, single-use, disposable glove intended for medical purposes to be worn on the hands of examiners to prevent contamination between an examiner and the patient. The gloves are made of nitrile butadiene rubber and are white-colored and powder-free. The gloves are offered in one version in a range of sizes: x-small, small, medium, large, and x-large.
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