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510(k) Data Aggregation

    K Number
    K023577
    Device Name
    POWDER FREE LATEX EXAM GLOVES, POLY COATED NATURAL AND/OR COLORED, WITH PROTEIN LABELING (<50UN/G)
    Manufacturer
    YTY INDUSTRY (MANJUNG) SDN. BHD.
    Date Cleared
    2002-12-06

    (44 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K014134,K000156
    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 examiner.

    Device Description

    Powder Free, Natural and/or Colored Latex Exam Gloves, with Protein labeling (

    AI/ML Overview

    This document describes the acceptance criteria and performance of Powder Free, Natural and/or Colored Latex Exam Gloves, with Protein labeling (

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