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510(k) Data Aggregation

    K Number
    K981979
    Device Name
    UNISEAL GLOVES LOW PROTEIN POWDERED
    Manufacturer
    AMERICAN HEALTHCARE PRODUCTS (M) SDN BHD
    Date Cleared
    1998-11-30

    (178 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 :

    UNISEAL GLOVES LOW PROTEIN POWDERED

    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

    Uniseal Powdered Latex Examination Glove with Protein Content Labeling Claim (100 micrograms or less)

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for a medical device (Uniseal Latex Examination Gloves) and primarily discusses the regulatory approval process. It does not include details about device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.

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