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510(k) Data Aggregation

    K Number
    K230137
    Device Name
    Reliance® Fusion Sterilization Wraps
    Date Cleared
    2023-12-07

    (323 days)

    Product Code
    Regulation Number
    880.6850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ahlstrom-Munksjo Nonwovens LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Reliance® Fusion Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider via the following: - . Pre-vacuum Steam 270°F/132°C for 4 minutes - Dry time of 12 minutes for Fusion Light O - Dry time of 20 minutes for Fusion Heavy O - Pre-vacuum steam sterilization of two stainless steel lumens 3 mm in diameter or larger and 400 mm in O length or less. - 100% Ethylene Oxide (EO) with a concentration of 725-759 mg/L @ 131°F/55°C and 40% 70% relative ● humidity for 60 minutes - Aeration time of 8 hours at 55oC O - Ethylene oxide sterilization of two stainless steel lumens 3 mm in diameter or larger and 400 mm in O length or less.
    Device Description
    The Reliance® Fusion Sterilization Wraps are square or rectangular nonwoven sheets consisting of two layers of nonwoven ultrasonically bonded together along two edges for convenient simultaneous wrapping of one or a collection of medical devices that will be sterilized following standard healthcare practices. The Fusion wraps consist of two distinct nonwovens for each layer. Outer Layer: SMS nonwoven layer produced using a spunbond-meltblown-spunbond process and composed of polypropylene with blue pigment and an anti-static treatment. Inner Layer: Wetlaid nonwoven, produced using a wood pulp process, composed of natural wood pulp and synthetic fibers bonded with a synthetic binder, containing green pigment and treated to impart hydrophilic properties. The Reliance® Fusion Sterilization Wraps allow a sterilized package of medical devices to be opened aseptically and are supplied in a variety of sheet sizes ranging from 12 in. x 12 in. The Sterilization Wraps have no intended patient contact and are supplied non-sterile. They are for Single Use Only.
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