LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K081180
    Device Name
    SKINSENSE POLYISOPRENE UNDERGLOVE
    Manufacturer
    MOLNLYCKE HEALTH CARE US, LLC
    Date Cleared
    2008-08-26

    (123 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 :

    SKINSENSE POLYISOPRENE UNDERGLOVE

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

    The Skinsense Polyisoprene Underglove is a disposable device made of non-natural rubber latex that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.

    Device Description

    The Skinsense Polyisoprene Underglove is a sterile powder free, polymer coated latex surgical glove. The glove contains 50 micrograms or less of total water extractable protein per gram.

    AI/ML Overview

    This document is a 510(k) summary for a medical device called the "Skinsense Polyisoprene Underglove." It describes characteristics and performance data related to physical properties and biocompatibility.

    1. Table of Acceptance Criteria and Reported Device Performance

    CharacteristicAcceptance Criteria (Standard)Reported Device Performance
    DimensionsMeets ASTM D3577Meets ASTM D3577
    Physical PropertiesMeets ASTM D3577Meets ASTM D3577
    Freedom from HolesMeets ASTM D3577Meets ASTM D3577
    Biocompatibility:
    Cytotoxicity StudyPassPass
    ISO Skin Irritation StudyPassPass
    LAL Test
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1