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510(k) Data Aggregation

    K Number
    K211714
    Device Name
    Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy)
    Date Cleared
    2021-08-04

    (62 days)

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

    Hengchang (Dongying) Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient 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. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
    Device Description
    The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: small, medium, large, and extralarge.
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