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510(k) Data Aggregation

    K Number
    K241565
    Device Name
    Sterilization Package/Reel
    Manufacturer
    Anqing Clean Dental Instrument Technology Co., Ltd.
    Date Cleared
    2025-02-24

    (269 days)

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

    Anqing Clean Dental Instrument Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sterilization Package/Reel is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows: · Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 30 minutes. · Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% to 80% relative humidity for 60 minutes. Aeration time of 8 hours at 60℃(140°F). Furthermore, the Sterilization Package/Reel maintains the enclosed devices up until 6 months post EO gas sterilization and maintains the enclosed devices up until 6 months post Steam sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the Sterilization Package/Reel has undergone either a steam or EO sterilization process. The Sterilization Package/Reel is offered 3 types in the following: Self -Seal Sterilization Pouch; Flat Sterilization Reel; Gusseted Sterilization Reel.
    Device Description
    The medical devices are inserted into the Sterilization Package/Reel,sealed, and then sterilized. After completion of the sterilization process, the Pouch/Roll main- tains the sterility of the enclosed medical devices until the seal is opened. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 6 months post Steam or EO gas sterilization. The Self-seal Sterilization Package permits the sealing of the pouch without the need of heat-sealing equipment, while the Heat-Seal Sterilization Reel are heat-sealed prior to processing in the steam/or EO Sterilization. The chemical indicators ink printed on the "medical dialysis paper" will exhibit a color change after the Package/Reel is exposed to steam or ethylene oxide gas. The color of the Chemical Indicator changes from blue to black when exposed to Steam. And the color changes from pink to yellow, when exposed to EO gas. The Chemical Indicator which is Type 1 Process Indicator as categorized by ISO 11140-1:2014 offers an addition way to verity processing in the sterilization cycle. The Chemical Indicator should be used in addition to, 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.
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