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510(k) Data Aggregation

    K Number
    K241036
    Device Name
    Autoclave Indicator Tape; EO Indicator Tape
    Manufacturer
    Jiangmen New Era External Use Drug Co., Ltd
    Date Cleared
    2024-12-17

    (245 days)

    Product Code
    JOJ
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Jiangmen New Era External Use Drug Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Autoclave Indicator Tape is designed for use by a health care provider to demonstrate that the unit or load has been exposed to a steam sterilization process and to distinguish between processed units or loads. After steam sterilization, the chemical indicator lines will show a visual color change from yellow to Black. This is a single use, disposable device(s), and provided non-sterile. The Autoclave Indicator Tape can be used in the following steam sterilization cycles: 1. Gravity: 121°C, 30 minutes 2. Vacuum assisted (pre-vacuum): 134°C, 4 minutes EO Indicator Tape is designed for use by a healthcare provider to demonstrate that the unit or load has been exposed to an EO gas sterilization process and to distinguish between processed units or loads. The chemical indicator lines turn from Orange to Green when exposed to EO gas sterilization conditions. This is a single use, disposable device(s), and provided non-sterile. The EO Indicator Tape can be used in the following EO sterilization cycle: 55°C, 762mg/l EO, 40~80%RH, 4 hours exposure
    Device Description
    Autoclave Indicator Tape is a single chemical indicator designed for steam sterilizing monitoring. The diagonal strips are printed along the length of the tape using chemical indicator ink. During the sterilization cycle, the initial yellow color of the indicator ink on the autoclave indicator tape changes to Black. If no color change occurs, it may indicate that the autoclave indicator tape was not exposed to the sterilization process due to equipment malfunctions or procedural errors during the sterilization process. This is a single use, disposable device(s), and provided non-sterile. EO Indicator Tape is single chemical indicator designed for use in ethylene oxide sterilizing processes. The diagonal strips are printed along the length of the tape using chemical indicator ink. During the sterilization cycle, the initial orange color of the indicator ink on the EO indicator tape changes to green. If no color change occurs, it may indicate that the EO indicator tape was not exposed to the sterilization process due to equipment malfunctions or procedural errors during the sterilization process. This is a single use, disposable device(s), and provided non-sterile.
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