Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K250321
    Device Name
    GCI Sterilization Wrappers
    Manufacturer
    George Courey Inc.
    Date Cleared
    2025-06-06

    (122 days)

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

    George Courey Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GCI Sterilization Wrappers are intended to be used to enclose reusable textile-based medical devices, such as surgical gowns, towels, and drapes, for sterilization by a health care provider. They are designed to allow effective steam sterilization of the enclosed textile items and to maintain sterility until use, for up to 28 days. GCI Sterilization Wrapper sizes and validated load limitations are as follows: | SKU / Model | Size | Border Color | Maximum Validated Load Weight | |---|---|---|---| | P81818 KBRO | 18"x18" | White | 1 lbs | | P82424 KBRO | 24"x24" | Pink | 1.82 lbs | | P83030 KBRO | 30"x30" | Yellow | 3.45 lbs | | P83636 KBRO | 36"x36" | Blue | 5.8 lbs | | P84545 KBRO | 45"x45" | Mint | 10.98 lbs | | P85454 KBRO | 54"x54" | Red | 18.5 lbs | | P86060 KBRO | 60"x60" | Green | 25 lbs | GCI Sterilization Wrappers are reusable through 38 wash, dry, and sterilization cycles. Pack assembly should follow established folding, assembly, and wrapping procedures as defined by the clinical staff for aseptic presentation of the pack and its contents. Closure can include autoclave tape and elastomer closures. Sterilization: A prevacuum steam sterilization cycle (4 minutes exposure at 132°C, Dry Time: 30 minutes) has been validated.
    Device Description
    GCI Sterilization Wrappers are intended to enclose a textile-based medical device for sterilization and maintain sterility of the enclosed device until used. The proposed devices are medical devices that are provided non-sterile. They may be reused up to 38 times. They are available in multiple sizes to accommodate textile-based medical devices, ranging from 18"x18" to 60"x60". The size is indicated by color coding of the wrap borders for easy identification. Load sizes should be large enough to prevent too much overlapping of the wrapper material (such that all but one side of the wrapper should be a single layer when properly folded) to allow appropriate sterilant penetration. Load sizes should be small enough to overlap by at least 2 inches on the remaining side to ensure there are no gaps.
    Ask a Question

    Page 1 of 1