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510(k) Data Aggregation

    K Number
    K243431
    Device Name
    Medicom Sterilization Pouch and Reel
    Manufacturer
    Medicom Asia-Pacific Holdings Ltd. Taiwan Branch.
    Date Cleared
    2025-02-21

    (108 days)

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

    Medicom Asia-Pacific Holdings Ltd. Taiwan Branch.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medicom Sterilization Pouch and Reel are intended to provide health care workers with an effective method to enclose devices, and they can use Single Pouch or Double Pouches intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows: - · Gravity steam at 121°C (250°F) for 30 minutes; Drying time of 25 minutes. - Pre-vacuum steam at 132°C (270°F) for 4 minutes; Drying time of 20 minutes. - · Pre-vacuum steam at 134°C (273°F) for 4 minutes; Drying time of 20 minutes. - · Ethylene Oxide (EO) with a concentration of 600 mg/L at 50°C (122°F) and 60% to 85% relative humidity for 120 minutes. Single Pouch: Aeration time of 5 days at 25°C (77°F). Double Pouches: Aeration time of 3 days at 25°C (77°F). Furthermore, there are 3 thicknesses for health care workers to choose from as follows: - · Pouch of Combination A: Medical grade paper 60g+laminated film 44/m - Pouch of Combination B: Medical grade paper 60g+laminated film 52um - · Pouch of Combination C: Medical grade paper 70g+laminated film 52um The Medicom Sterilization Pouch and Reel which are made with Paper maintains the sterility of the enclosed devices for up to 1 year post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.
    Device Description
    The medical devices are inserted into the Medicom Sterilization Pouch and Reel, sealed, and then sterilized in the Sterilization System. After completion of the sterilization process, the Pouch/Reel maintains the sterility of the enclosed medical devices until the seal is opened. And they can use Single Pouch or Double Pouches intended for sterilization in the Steam or via Ethylene Oxide (EO). The device is intended to allow the sterilization of enclosed devices and maintain sterility for the enclosed devices until used up to 1-year post-steam or EO gas sterilization. The Self-seal pouch permits the sealing of the pouch without heat-sealing equipment, while the heat-sealed pouches and reels are heat-sealed before processing in the steam/or EO Sterilization. The chemical indicators printed on the "medical grade paper" will exhibit color change after the pouch is exposed to steam or ethylene oxide gas. The "Medicom Sterilization Pouch and Reel" is printed with dual chemical indicators that the color change from Red/Pink to Cocoa when exposed to Steam, and the color changes from Blue to Golden Yellow /Brown, when exposed to EO gas. The Chemical Indicator offers an additional way to verify processing in the sterilization cycle. The Chemical Indicator should be used in addition to, but not in place of, the biological indicator. The Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to Steam/or EO gas. Furthermore, there are 3 thicknesses with dimensions for health care workers to choose from as follows: - Pouch of Combination A: Medical grade paper 60g+laminated film 44um Dimensions of 880 series: W: 57mm ~ 415mm; L: 127mm~727mm Dimensions of 870 series: W: 89mm ~ 457mm; L: 159mm~635mm Dimensions of 95 series: W: 50mm ~ 250mm; L: ~30.5M - Pouch of Combination B: Medical grade paper 60g+laminated film 52um Dimensions of 881 series: W: 57mm ~ 381mm; L: 127mm~797mm Dimensions of 871 series: W: 89mm ~ 457mm; L: 159mm~559mm Dimensions of 951 series: W: 50mm ~ 250mm; L: ~200M - · Pouch of Combination C: Medical grade paper 70g+laminated film 52um Dimensions of 882 series: W: 57mm ~ 381mm; L: 127mm~797mm Dimensions of 872 series: W: 89mm ~ 457mm; L: 159mm~559mm Dimensions of 952 series: W: 50mm ~ 250mm; L: ~200M
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