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510(k) Data Aggregation

    K Number
    K032323
    Date Cleared
    2003-10-07

    (71 days)

    Product Code
    Regulation Number
    880.6250
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

    Device Description

    Powdered Synthetic Vinyl Patient Examination Gloves, Yellow

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Long First (Xiamen) Plastics Company Limited regarding their "Brothers Powered Synthetic Vinyl Patient Examination Gloves Yellow." This document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    The letter is a regulatory approval document stating that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. It discusses regulatory compliance, labeling, and other administrative aspects, but not performance testing details.

    Therefore, I cannot extract the requested information as it is not present in the provided text.

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