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510(k) Data Aggregation

    K Number
    K060658
    Device Name
    BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE, BLACK COLOR)
    Manufacturer
    BRIGHTWAY HOLDINGS SDN. BHD.
    Date Cleared
    2006-04-10

    (54 days)

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

    BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE, BLACK COLOR)

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

    BRIGHTWAY™ Brand Latex Examination Glove ( Powder Free, Black Color ) containing 50 µgm or less of water extractable protein per gram is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding "BRIGHTWAY™ Brand Latex Examination Gloves (Power Free, Black Color) Containing 50 ug or Less of water Extractable Protein Per Gram". It details the FDA's determination of substantial equivalence to legally marketed predicate devices.

    However, the provided text does not contain information about acceptance criteria, device performance results, sample sizes for testing or training, expert ground truth establishment, or any details about a study and its methodology as requested in your prompt. The document is an administrative approval letter, not a scientific study report.

    Therefore, I cannot populate the table or answer the subsequent questions based on the information provided in the input.

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