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510(k) Data Aggregation

    K Number
    K072488
    Device Name
    LANFAN POWDER-FREE VINYL EXAM GLOVES
    Date Cleared
    2007-10-19

    (45 days)

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

    SHANGHAI LANFAN CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A Powder-free Vinyl Patient Examination Glove is disposable device made of PVC material that coated with PU coating to facilitate donning and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials individual contaminants.
    Device Description
    The Powder-free vinyl exam glove is a disposable Class 1 medical device made from PVC material and is intended to be worn on the hands of health care personnel for medical purpose to provide a barrier against potentially infectious materials and other contaminants.
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