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510(k) Data Aggregation

    K Number
    K141438
    Device Name
    WHITNEY MEDICAL SOLUTIONS ESHIELD
    Manufacturer
    WHITNEY MEDICAL SOLUTIONS
    Date Cleared
    2014-08-14

    (76 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    WHITNEY MEDICAL SOLUTIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Whitney Medical Solutions equipment drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting. These drapes are used to protect the equipment from contamination during various procedures.
    Device Description
    The Whitney Medical Solutions' eShield consists of polyethylene film (and an adhesive pad in some models) with tear guide tape and a zipper that allows the cover to be torn fairly straight across it. There is also a double sided tape below the zipper that is used as a redundant closure method with the cover being folded twice and sealed against it. The device is provided to the user sterile, is labeled for single use only and not intended for resterilization or reprocessing. The sterile eShield is sterilized using a validated irradiation sterilization method.
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