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510(k) Data Aggregation

    K Number
    K012048
    Device Name
    POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE
    Manufacturer
    WRP ASIA PACIFIC SDN. BHD.
    Date Cleared
    2001-08-16

    (48 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    K022095
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Powder Free Neoprene Examination Gloves, Non Sterile is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

    Device Description

    The Powder Free Neoprene Examination Gloves, Non Sterile meets all the The Towder 1160 - Neopandard D 3578 - 00 and FDA 21 CFR 800.20.

    AI/ML Overview

    The provided document describes the WRP Asia Pacific Sdn Bhd "Powder Free Neoprene Examination Gloves, Non-Sterile". Here's an analysis of the acceptance criteria and the study data as requested:

    Acceptance Criteria and Device Performance for Powder Free Neoprene Examination Gloves, Non-Sterile

    1. Table of Acceptance Criteria and Reported Device Performance:

    CharacteristicAcceptance Criteria (Standard)Reported Device Performance
    DimensionsASTM D 3578 - 00Meets
    Physical PropertiesASTM D 3578 - 00Meets
    Freedom from pinholesASTM D 3578 - 00 & FDA 21 CFR 800.20Meets
    Powder-FreeASTM D 6124 - 00Meets (
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