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510(k) Data Aggregation

    K Number
    K213087
    Device Name
    Natural Rubber Latex Ultrasound Transducer Probe Covers
    Manufacturer
    Global Protection Corp.
    Date Cleared
    2022-06-07

    (256 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Intended for barrier protection during procedures of endocavity ultrasound examination and diagnosis to help prevent transfer of microorganism, body fluids and particulate material.

    Device Description

    Natural Rubber Latex Ultrasound Transducer Probe Covers

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for a medical device: "Natural Rubber Latex Ultrasound Transducer Probe Covers." This document does not contain information about acceptance criteria or a study proving that an AI/ML powered device meets acceptance criteria.

    The submission is for a physical medical device (ultrasound probe covers), not an AI/ML software device. Therefore, the questions regarding AI/ML device performance, ground truth, expert consensus, and training/test sets are not applicable to the content provided.

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