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510(k) Data Aggregation

    K Number
    K042574
    Device Name
    ESTEEM BLUE POLYISOPRENE SURGICAL GLOVES WITH COATING (CONTAINING CHITOSAN, PROVITAMIN B, GLUCONOLACTONE AND GLYCEROL)
    Manufacturer
    Cardinal Health
    Date Cleared
    2004-12-08

    (77 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K011721
    Why did this record match?
    Reference Devices :

    K011721

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

    These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination in environments within hospitals and other healthcare facilities. These gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility.

    Device Description

    Esteem Blue Polyisoprene Surgical Gloves with coating are formulated using Synthetic Rubber Latex. These are offered powder-free and sterile.

    AI/ML Overview

    This document describes acceptance criteria and testing for the Esteem Blue Polyisoprene Surgical Gloves with Coating.

    1. Table of Acceptance Criteria and Reported Device Performance:

    Test/CharacteristicAcceptance Criteria (Set by Regulations/Standards)Reported Device Performance
    Primary Skin IrritationNot explicitly stated in the provided text, but implied as "non-irritating" for safe use.Gloves are non-irritating.
    Guinea Pig MaximizationNot explicitly stated in the provided text, but implied as not causing sensitization for safe use.Gloves do not display any potential for sensitization.
    Ultimate Elongation & Tensile StrengthExceed requirements for rubber surgical gloves per ASTM D3577-01a2.Gloves exceed requirements for rubber surgical gloves per ASTM D3577-01a2.
    Barrier DefectsExceed requirements per 21 CFR §800.20 and ASTM D3577-01a2, with an Acceptance Quality Limit (AQL) of 1.5.Gloves exceed requirements per 21 CFR §800.20 and ASTM D3577-01a2, AQL = 1.5.
    Powder LevelMeet powder level requirements for "Powder Free" designation using ASTM Standard D6124-01 (implied
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