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510(k) Data Aggregation

    K Number
    K052772
    Device Name
    BARRIERPLUS GOLD ORTHO POWDER-FREE SYNTHETIC POLYISOPRENE ORTHOPEDIC SURGICAL GLOVES
    Manufacturer
    BARRIERMED GLOVE CO.
    Date Cleared
    2005-12-20

    (78 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BARRIERPLUS GOLD ORTHO POWDER-FREE SYNTHETIC POLYISOPRENE ORTHOPEDIC SURGICAL GLOVES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    BarrierPlus® Gold Ortho Powder-free Synthetic Polyisoprene Orthopedic Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination.

    Device Description

    BarrierPlus® Gold Ortho Powder-free Synthetic Polyisoprene Orthopedic Surgical Glove

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a surgical glove, not a study report for a diagnostic device or AI algorithm. Therefore, it does not contain the information required to answer your prompt. The document is an approval letter for a medical device (surgical gloves) and discusses regulatory compliance rather than performance studies or acceptance criteria in the context of device accuracy or effectiveness for diagnostic purposes.

    Specifically, the document does not provide:

    • A table of acceptance criteria and reported device performance.
    • Sample sizes for test sets, data provenance, or details about the ground truth.
    • Information on expert adjudication, MRMC studies, or standalone algorithm performance.
    • Details about training sets or how ground truth for training was established.
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