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510(k) Data Aggregation

    K Number
    K974443
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVES - POLYMER COATED
    Manufacturer
    P.T. LATEXINDO TOBAPERKASA
    Date Cleared
    1998-01-05

    (41 days)

    Product Code
    LYZ,LZY
    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 Medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

    Device Description

    Powder Free Nitrile Examination Gloves (Polymer Coated)

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for medical gloves. It does not contain information about acceptance criteria or a study proving that a device meets those criteria. The provided text is a notification of substantial equivalence for "Powdered Free Nitrile Examination Gloves (Polymer Coated)."

    Therefore, I cannot provide the requested information based on the input document.

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