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510(k) Data Aggregation

    K Number
    K151684
    Device Name
    Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim(Blue)
    Manufacturer
    HARTALEGA NGC SDN. BHD.
    Date Cleared
    2015-09-18

    (88 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 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) is a non - sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner

    Device Description

    Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)

    AI/ML Overview

    Analysis of Information Provided:

    The provided document is an FDA 510(k) clearance letter for a "Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)". This document pertains to regulatory approval for a medical device that falls under the category of patient examination gloves.

    The content of this document does not include information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device. The document is a regulatory approval for a physical medical device (gloves) and focuses on substantial equivalence to a predicate device, general controls, and compliance with specific FDA regulations for such devices.

    Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) for an AI/ML device from this particular document.

    Summary of Device and Approval:

    • Device Name: Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
    • Regulation Number: 21 CFR 880.6250
    • Regulation Name: Patient Examination Glove
    • Regulatory Class: I
    • Product Code: LZA
    • Approval Type: 510(k) Premarket Notification (substantial equivalence)
    • Indications for Use: Non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    • Type of Use: Over-The-Counter Use (21 CFR 801 Subpart C)

    Conclusion regarding requested AI/ML study information:

    The provided document is irrelevant to the request about acceptance criteria and studies for an AI/ML device. It is a regulatory approval for a physical medical glove.

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