Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K211810
    Device Name
    Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl)
    Date Cleared
    2022-05-23

    (346 days)

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

    PT. Shamrock Manufacturing Corpora

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05(2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs and Fentanyl.
    Device Description
    Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentany) are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners as a barrier protection to prevent contamination between a patient and an examiner. The qloves are powder free, ambidextrous, blue color, and beaded cuff. The gloves are designed and manufactured in accordance with the ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application. The gloves are also complied with requirements for Standard Practice for Assessment of resistance of Medical Gloves to Permeation by Chemotherapy Drugs and Fentanyl as per ASTM D6978-05 (Reapproved 2019).
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1