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510(k) Data Aggregation

    K Number
    K201351
    Device Name
    Maxima Surgical Gown
    Manufacturer
    Date Cleared
    2022-03-11

    (659 days)

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

    Elevate Textiles

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The reusable Maxima Surgical Gown is intended to be used by operating room personnel during surgical procedures to help protect both the patient and the health care worker from transfer of micro-organisms, body fluids, and particulate material. The reusable Maxima Surgical Gown is provided non-sterile. Sterilization parameters are as follows: * Prevac Steam Sterilization - 135°C/274°F (temperature) / 3 minutes (exposure time) / 20 minutes (dry time)
    Device Description
    The Maxima® Surgical Gown is a reusable woven surgical gown for use in sterile conditions. It is made of 100% filament polyester that provides AAM PB70:2012 Level 3 Liquid Barrier Performance Barrier in the critical zone up to 75 reprocessing cycles. The back of the gown provides AAMI Level 3 Liquid Barrier Performance Barrier up to 75 reprocessing cycles. The seam in the sleeves are sealed with a permanent seam tape which seals the stitch area enabling it to perform as AAMI Level 3 up to 75 reprocessing cycles. Maxima® Surgical Gown will be manufactured in small, medium, and larges sizes. Maxima® Surgical Gowns will be sold as non-sterile reusable surgical gowns that are to be laundered, sterilized and processed by health care facilities and or contract laundry and sterliization companies before first use and after each subsequent use.
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