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510(k) Data Aggregation

    K Number
    K071565
    Device Name
    BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENT
    Manufacturer
    MOLNLYCKE HEALTH CARE US, LLC
    Date Cleared
    2007-09-10

    (95 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K980942,K060030
    Predicate For
    K101163
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Biogel® Indicator™ Underglove is a disposable device made of 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 Biogel® Indicator™ 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 510(k) summary describes the Biogel® Indicator™ Underglove, a sterile powder-free latex surgical glove. The device is classified as a Class I surgical glove (CFR 878.4461).

    Here's an analysis of the provided information covering the acceptance criteria and the study that proves the device meets them:

    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
    BiocompatibilityMeets ISO 10993-1Meets ISO 10993-1
    LAL Test - final endotoxin concentration
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