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510(k) Data Aggregation

    K Number
    K021784
    Device Name
    PROFEEL POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM)
    Manufacturer
    WRP ASIA PACIFIC SDN. BHD.
    Date Cleared
    2002-07-24

    (55 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    K070619
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The surgeon's glove is a device made of natural rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.

    Device Description

    The Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim) meets all the requirements of ASTM standard D 3577-0151 and FDA 21 CFR 800.20.

    AI/ML Overview

    Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study proving the device meets them:

    1. Table of Acceptance Criteria and Reported Device Performance:

    CharacteristicAcceptance Criteria (Standards)Reported Device Performance
    DimensionsASTM D 3577 - 01E1Meets
    Physical PropertiesASTM D 3577 - 01E1Meets
    Freedom from pinholesASTM D 3577 - 01E1; FDA 21 CFR 800.20Meets
    Powder-FreeASTM D 6124 - 01Meets (2 mg/glove maximum)
    Protein LevelASTM D 5712 – 95
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