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510(k) Data Aggregation

    K Number
    K171171
    Device Name
    KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black)
    Manufacturer
    Koon Seng Sdn. Bhd.
    Date Cleared
    2018-02-22

    (307 days)

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

    Koon Seng Sdn. Bhd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder-free patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
    Device Description
    KS Medicare Powder-Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, meeting all the requirement of ASTM standards D6319-10 (Reapproved 2015), ASTM D6978-05 and ASTM D6124-06 (Reaffirmation 2011). Principle of operation: KS Medicare Powder-Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, are non-sterile single use only, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between the patient and examiner. This powder free nitrile examination glove is manufactured from synthetic rubber. A process known as chlorination has been incorporated in the manufacturing of the gloves that don easily for the user without the addition of powder. Chlorination is a process wherein examination gloves are exposed to chlorine gas or a hypochloritehydrochloric acid mixture in order to harden the surface of the glove. The hardening of the glove surface decreases the surface friction of the glove thereby allowing for gloves to be easily donned without powder. The gloves are ambidextrous and offered in three sizes: small, medium, and large.
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