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510(k) Data Aggregation

    K Number
    K183389
    Device Name
    Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove
    Manufacturer
    Hartalega NGC Sdn. Bhd.
    Date Cleared
    2019-06-28

    (204 days)

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

    The Polyisoprene Powder Free Surgical Glove is a disposable device that is intended to be worn the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminations.
    The Polyisoprene Powder Free Surgical Underglove is a disposable device that is intended to be worn the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminations.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria and study proving device performance for "Polyisoprene Powder Free Surgical Glove" or "Polyisoprene Powder Free Surgical Underglove". The document is an FDA 510(k) clearance letter and an Indications for Use statement, which confirms the device is substantially equivalent to legally marketed predicate devices and describes its intended use. It does not include details on specific performance studies or acceptance criteria beyond general regulatory compliance.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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