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510(k) Data Aggregation

    K Number
    K991778
    Device Name
    LATEX EXAMINATION GLOVES POLYMER COATED (POWDER-FREE)
    Manufacturer
    SELTOM PACIFIC SDN. BHD.
    Date Cleared
    1999-08-31

    (98 days)

    Product Code
    LYY
    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

    A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient. It is a single use disposable glove.

    Device Description

    Latex Examination Gloves Polymer Coated (Powder-Free)

    AI/ML Overview

    This looks like a 510(k) clearance letter for latex examination gloves, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, and AI/ML specific performance metrics is not applicable to this document.

    The document states that the device is "substantially equivalent" to predicate devices, which is the standard for 510(k) clearance for many medical devices, particularly those that are well-established.

    Therefore, I cannot provide the information requested in the format of the table or answer the specific questions related to AI/ML device studies.

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