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510(k) Data Aggregation

    K Number
    K011995
    Device Name
    POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
    Manufacturer
    QUALITY LATEX PRODUCTS MALAYSIA SDN BHD
    Date Cleared
    2001-07-31

    (35 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 patient examination glove is a disposable device intended for medical purpose and A patient Exammation grovent contamination between health care personnel and the patient.

    Device Description

    Polymer Coated Powder free latex examination gloves (with a protein label claim 50 MICKOGRAMS OR LESS

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for "Polymer Coated Latex Medical Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less)." This document is a regulatory approval and does not contain a study describing acceptance criteria, device performance metrics, or details of a clinical study for an AI-powered device.

    Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or expert involvement from the provided text. The document is strictly about the regulatory approval of a medical glove.

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