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510(k) Data Aggregation

    K Number
    K973830
    Device Name
    POWDER FREE PATIENT EXAMINATION GLOVE SAFE GLOVE
    Manufacturer
    SAFE GLOVE LTD.
    Date Cleared
    1998-01-16

    (101 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

    According to 21 CFR, 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 examiner.

    Device Description

    POWDER FREE LATEX PATIENT EXAMINATION GLOVES

    AI/ML Overview

    I am sorry, but the provided text does not contain the necessary information to answer your request. The document is an FDA 510(k) clearance letter for "POWDER FREE LATEX PATIENT EXAMINATION GLOVES" and does not detail acceptance criteria or a study that proves the device meets such criteria. It primarily addresses the regulatory approval of the gloves based on substantial equivalence.

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