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510(k) Data Aggregation

    K Number
    K100979
    Device Name
    NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR WHITE, NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR BLUE
    Manufacturer
    JIANGSU SUNSHINE PLASTIC PRODUCTS, CO. LTD
    Date Cleared
    2010-07-02

    (85 days)

    Product Code
    LZA
    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

    The 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

    Nitrile Exam Glove, Powder-Free Model Color White, Blue

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a Nitrile Exam Glove. It does not contain information about the acceptance criteria or a study that proves a device meets such criteria, as it is for a low-risk device (Class I) that typically does not require extensive clinical studies or performance acceptance criteria beyond established standards for gloves (e.g., integrity, barrier protection).

    Therefore, I cannot extract the requested information from the provided text.

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