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510(k) Data Aggregation

    K Number
    K990499
    Device Name
    PREPOWDERED NITRILE EXAMINATION GLOVES
    Manufacturer
    FLEXITECH SDN. BHD.
    Date Cleared
    1999-04-02

    (44 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    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

    Pre-Powdered Nitrile Examination Gloves

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA to FLEXITECH SDN. BHD. regarding "Pre-Powdered Nitrile Examination Gloves." This is not a study document that describes acceptance criteria and device performance data.

    Therefore, I cannot provide the requested information from this document. It does not contain details about:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for a test set.
    3. Number or qualifications of experts for ground truth.
    4. Adjudication method.
    5. MRMC comparative effectiveness study.
    6. Standalone algorithm performance.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    This document is primarily an FDA clearance letter for a medical device (nitrile gloves) based on substantial equivalence to a predicate device, rather than a report detailing performance studies against specific acceptance criteria for an AI/algorithm-based device.

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