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    K Number
    K111868
    Device Name
    STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIENT COATING
    Manufacturer
    CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES
    Date Cleared
    2011-09-21

    (82 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K042574
    Why did this record match?
    Device Name :

    STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIENT COATING

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

    This powder-free surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

    Device Description

    The proposed device is a disposable device intended for over the counter use and is provided sterile. It is not made with natural rubber latex. Instead, it is formulated from polyisoprene, which is synthetic rubber latex. This sterile polyisoprene powder-free surgical glove is manufactured using exact same material used in the currently cleared device, Esteem Blue glove (K042574) that has been legally marketed by Cardinal Health for many years. The glove is coated with emollient coating containing Glycerol, Gluconolactone, D-Sorbitol and Provitamin-B. The glove is manufactured using molds that feature anti-slip finish, independent thumb, and tapered mechanically locking cuffs to help reduce cuff roll down. It is offered powder-free and sterile.

    AI/ML Overview

    This document describes the regulatory submission for Sterile Polyisoprene Powder-Free Blue Surgical Gloves with Neu-Thera® Coating (hereinafter referred to as "the device"). The submission is a 510(k) premarket notification, indicating that the device is a modification of a currently marketed device (Esteem® Blue Sterile Polyisoprene Powder-Free Surgical Gloves with Neu-Thera Coating, cleared under 510(k) K042574).

    The document is a summary of safety and effectiveness, focusing heavily on comparative performance data with a predicate device rather than a comprehensive new device study. Therefore, many of the typical elements of an AI/ML device acceptance criteria and study are not applicable in this context.

    Here's an analysis based on the provided text, addressing the points you requested:

    1. Table of Acceptance Criteria and Reported Device Performance

    For this medical device (surgical gloves), the "acceptance criteria" are based on meeting established industry standards (ASTM and ISO) and regulatory requirements (21 CFR). The "performance" is demonstrated by showing that the new device meets these standards and is comparable to the predicate device.

    CharacteristicAcceptance Criteria (Standard/Test/FDA Guidance)Reported Device Performance (Results Summary)
    Biocompatibility
    Primary Skin IrritationISO 10993-10Gloves are non-irritating.
    Guinea Pig MaximizationISO 10993-10Gloves do not display any potential for sensitization.
    Physical Characteristics
    DimensionsASTM D3577Meet requirements
    Physical PropertiesASTM D3577Meet requirements for rubber surgical gloves
    Freedom from Holes21 CFR 800.20 & ASTM D3577 (Tested in accordance with ASTM D5151)Tested in accordance with ASTM D5151 with acceptable results (AQL meets 21CFR 800.20 & ASTM D3577 requirements).
    Powder ResidualASTM D3577 (≤2.0 mg/glove for "Powder-Free" designation, tested using ASTM D6124)Gloves meet powder level requirements for "Powder-Free" designation per ASTM D3577. Results generated values
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