LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K032942
    Device Name
    PROFEEL POWDER FREE, PLOYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE
    Manufacturer
    WRP ASIA PACIFIC SDN. BHD.
    Date Cleared
    2003-12-17

    (86 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PROFEEL POWDER FREE, PLOYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The surgeon's glove is a device made of synthetic 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 Polyisoprene Surgical Glove, Sterile, meets all the requirements of ASTM standard D 3577 - 01a52 and FDA 21 CFR 800.20.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the WRP Asia Pacific Sdn Bhd surgical gloves, based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    CHARACTERISTICSSTANDARDSACCEPTANCE CRITERIA (Implicit in "Meets")REPORTED DEVICE PERFORMANCE
    DimensionsASTM D 3577 - 01aF2Meets ASTM D 3577 - 01aF2Meets
    Physical PropertiesASTM D 3577 - 01aF2Meets ASTM D 3577 - 01aF2Meets
    Freedom from pinholesASTM D 3577 - 01aF2, FDA 21 CFR 800.20Meets ASTM D 3577 - 01aF2, FDA 21 CFR 800.20Meets
    Powder-FreeASTM D 6124 - 01
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1