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510(k) Data Aggregation

    K Number
    K210405
    Device Name
    ProTEC-USA EZDoff Gown
    Manufacturer
    Cadillac Products, Inc.
    Date Cleared
    2021-12-15

    (308 days)

    Product Code
    QPC, OPC
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cadillac Products, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ProTEC-USA EZDoff Gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. The ProTEC-USA EZDoff Gown is a single use, disposable gown provided non-sterile. The back of the gown is open and non-protective. The gown is not intended for use in the operating room.
    Device Description
    The ProTEC-USA EZDoff Gown is constructed of 41 gsm blue polyolefin (Polyethylene) film offered in one universal size. The body of the gown is provided with belt ties that are constructed of the same 41 gsm blue polyolefin (Polyethylene) film. The sleeves of the gown are sealed using a heat-sealing method.
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