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510(k) Data Aggregation

    K Number
    K991043
    Device Name
    LATEX EXAMINATION GLOVES POWDERED, LOW PROTEIN
    Manufacturer
    GLOVCO (M) SDN. BHD.
    Date Cleared
    1999-05-04

    (36 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 :

    LATEX EXAMINATION GLOVES POWDERED, LOW PROTEIN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A patient examination glove that is worn by the healthcare or similar personnel to prever t contamination setween the healthcare and the patient.

    Device Description

    Powdered Latex Examination Gloves with Protein Labeling Claim

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for "Latex Examination Gloves Powdered, with Trade Name: Protein Labeling Claim (50 Micrograms or Less Per Gram)". This document is a regulatory approval and does not contain the acceptance criteria or a study proving the device meets the acceptance criteria for an AI/ML powered device.

    The letter states that the device is "substantially equivalent" to predicate devices, meaning it has similar indications for use, safety, and effectiveness. However, it does not detail specific performance metrics, sample sizes, expert ground truth, or study designs that would be relevant for evaluating an AI/ML diagnostic or screening device.

    Therefore, I cannot provide the requested information for acceptance criteria and a study proving the device meets those criteria based on the input document. The input relates to the regulatory approval of a physical medical device (gloves), not an AI/ML software device.

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