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510(k) Data Aggregation

    K Number
    K991686
    Device Name
    LATEX EXAMINATION GLOVES, POWDER FREE WITH PROTEIN LABELING CLAIM (50 MCG OR LESS)
    Manufacturer
    ARISTA LATINDO INDUSTRIAL, LTD. P.T.
    Date Cleared
    1999-06-11

    (25 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K921389
    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 that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    Powder Free Natural Latex Examination Gloves with Protein Claim (50mcg or less EXTRACTABLE PROT

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for "Latex Examination Gloves, Powder Free with Protein Labeling Claim, (50 mcg or less)". It does not contain information about the acceptance criteria and study proving device meets the acceptance criteria in the format requested.

    The document primarily states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It details general regulatory provisions and contact information for further inquiries.

    Therefore, I cannot provide the requested table and study information based on the given input.

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