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510(k) Data Aggregation

    K Number
    K992018
    Device Name
    LAGLOVE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS)
    Manufacturer
    LAGLOVE (M) SDN. BHD.
    Date Cleared
    1999-07-30

    (44 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    LAGLOVE™ Brand Latex Surgical Gloves - Sterile (Powdered), containing 150 ugm or less of water extractable protein per gram is a disposable glove made of Natural Rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

    Device Description

    LAGLOVE™ Brand Latex Surgical Gloves - Sterile (Powdered) Containing 150 µgm or less of water Extractable protein per gram.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and study detailed in the request. The document is an FDA 510(k) clearance letter for latex surgical gloves, focusing on regulatory approval and substantial equivalence, not on specific performance acceptance criteria or studies as typically applied to medical devices with measurable outputs like AI algorithms. Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, ground truth, experts, or MRMC studies.

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