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510(k) Data Aggregation

    K Number
    K173304
    Device Name
    Finessis Intense Polyisoprene Surgical Glove
    Manufacturer
    Lucenxia Prescience Ag
    Date Cleared
    2018-04-30

    (194 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This surgeon's glove is a device made of polyisoprene rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

    Device Description

    This surgeon's glove is a device made of polyisoprene rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a surgical glove. It does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria. The document is a regulatory approval for a medical device, specifically a surgical glove, based on its substantial equivalence to a legally marketed predicate device.

    Therefore, I cannot provide the requested information based on the given text.

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