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510(k) Data Aggregation

    K Number
    K012135
    Device Name
    POWDER FREE BROWN LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
    Manufacturer
    WRP ASIA PACIFIC SDN. BHD.
    Date Cleared
    2001-08-01

    (23 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    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 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 Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim) meets all the requirements of ASTM standard D 3577 - 00 and FDA 21 CFR 800.20.

    AI/ML Overview

    The provided document describes the acceptance criteria and performance of the WRP Asia Pacific Sdn Bhd "Powder Free Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim)". Here's a breakdown of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance

    CharacteristicsAcceptance Criteria (Standards)Reported Device Performance
    DimensionsASTM D 3577 - 00Meets
    Physical PropertiesASTM D 3577 - 00Meets
    Freedom from pinholesASTM D 3577 - 00; FDA 21 CFR 800.20Meets
    Powder-FreeASTM D 6124 - 00Meets (2 mg/glove maximum)
    Protein LevelASTM D 5712 - 95
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