Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K190782
    Device Name
    FlexGard Cut-Resistant Glove Liners
    Manufacturer
    Date Cleared
    2019-06-27

    (92 days)

    Product Code
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    LDI Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The FlexGard® Cut-Resistant Glove Liners are single use glove liners intended to help with protection against cuts when used with an inner and outer surgical glove. The glove liner must be worn between two surgical gloves.
    Device Description
    The FlexGard Cut Resistant Glove Liners provide an optional method of providing cut resistance to surgical gloves. The FlexGard Cut Resistant Glove Liners are applied between layers of surgical gloves. The FlexGard Cut Resistant Glove Liners are placed over a surgical glove and subsequently covered by a surgical glove. The FlexGard Cut Resistant Glove Liners are ambidextrous, there is no left or right handed Glove Liner variations. The FlexGard Cut Resistant Glove Liners are provided to the user terminally sterilized by a validated ethylene oxide process. The FlexGard Cut Resistant Glove Liners are labeled for single use. The FlexGard Cut Resistant Glove Liners provide protection against cuts and slashes. The FlexGard Cut Resistant Glove Liners are not puncture resistant or cut proof.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1