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510(k) Data Aggregation

    K Number
    K260181

    Validate with FDA (Live)

    Date Cleared
    2026-02-20

    (30 days)

    Product Code
    Regulation Number
    880.2800
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LF Process Indicator Tape for Steam Sterilization is designed to use on disposable wraps for sealing packs that are exposed to steam sterilization. The tape distinguishes between items processed and unprocessed in both gravity discharge and pre-vacuum steam sterilization processes. It is intended for use in gravity sterilizers operating at 121°C for 30 minutes, 132°C for 3 minutes, 132°C for 10 minutes, 132°C for 15 minutes, 135°C for 3 minutes and 135°C for 10 minutes. Pre-vacuum sterilizers operating at 132°C for 3 minutes, 132°C for 4 minutes, 134°C for 3 minutes, 134°C for 4 minutes and 135°C for 3 minutes. The green indicator lines turn dark brown/black once exposed to the steam process.

    Device Description

    The LF Process Indicator Tape for Steam Sterilization is designed to seal packs that are exposed to steam sterilization. The tape distinguishes between processed items and unprocessed in both gravity discharge and pre vacuum steam sterilization processes. Made of a saturated crepe paper printed with non-lead-based ink, the green indicator lines turn dark brown/black once exposed to the steam process. It is coated with a synthetic, solvent-free adhesive. This product is not made with natural rubber latex. Lead is not used in the manufacturing of the ink of indicator lines.

    AI/ML Overview

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