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510(k) Data Aggregation

    K Number
    K093696
    Device Name
    SR GLOVE, NU GLOVE, HIGHSTRESS MODEL 801, MODEL 802, MODEL 803
    Manufacturer
    CENTRAL MEDICARE SDN BHD
    Date Cleared
    2010-02-12

    (74 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SR GLOVE, NU GLOVE, HIGHSTRESS MODEL 801, MODEL 802, MODEL 803

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

    This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

    Device Description

    Blue Nitrile Examination Gloves, Powder Free

    AI/ML Overview

    The provided document refers to a 510(k) premarket notification for Blue Nitrile Examination Gloves, Powder Free, and does not contain information about acceptance criteria or a study proving that a device (in the context of AI/software) meets acceptance criteria. The document is an FDA letter granting substantial equivalence for medical gloves, and the "Indication for Use" section simply states the intended purpose of the gloves.

    Therefore, I cannot extract the requested information regarding acceptance criteria and a study from this document. The questions you've posed (sample size, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, ground truth types, training set size, and ground truth establishment for training) are all relevant to the evaluation of AI/software medical devices, but not to the type of device discussed in this document.

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