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510(k) Data Aggregation

    K Number
    K212998
    Device Name
    Powder Free Nitrile Examination Gloves (White, Blue and Black)
    Manufacturer
    Alcatron Gloves Factory
    Date Cleared
    2022-02-19

    (152 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

    The Powder free nitrile examination gloves (white, blue and black) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    Powder Free Nitrile Examination Gloves (White, Blue and Black)

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding "Powder Free Nitrile Examination Gloves (White, Blue and Black)". It confirms the device's substantial equivalence to legally marketed predicate devices and outlines general regulatory provisions. However, it does not contain any information about:

    • Acceptance criteria for device performance studies.
    • Results of a study proving the device meets acceptance criteria.
    • Sample sizes for test or training sets.
    • Data provenance.
    • Number or qualifications of experts.
    • Adjudication methods.
    • Multi-reader multi-case (MRMC) comparative effectiveness studies.
    • Standalone algorithm performance.
    • Type of ground truth used.
    • How ground truth was established for training sets.

    This document is a regulatory approval letter, not a study report detailing performance data. Therefore, I cannot generate the requested table and information based on the provided text.

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