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510(k) Data Aggregation

    K Number
    K974853
    Device Name
    LATEX (POWDER FREE) LOW PROTEIN
    Manufacturer
    P.T. HEALTHCARE GLOVINDO
    Date Cleared
    1998-02-09

    (42 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 purposes that is worn on the examiner's hand, or finger to prevent contamination between patient and examine.

    Device Description

    Latex Patient Examination Gloves, Powder-Free (with Protein Content Claim (50hicrogram or less) Labelling of Powder-Free)

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA regarding a latex, powder-free examination glove. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document confirms that the device is substantially equivalent to a predicate device marketed before May 28, 1976.

    Therefore, I cannot provide the requested information based on the provided text.

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