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510(k) Data Aggregation

    K Number
    K211540
    Device Name
    Edma Synthetic Nitrile Examination Gloves
    Manufacturer
    Edma Group, LLC
    Date Cleared
    2021-08-09

    (82 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K172015
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner.

    Device Description

    The subject device is powder free synthetic Nitrile patient examination gloves. The subject device is blue. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The subject device is non-sterile.

    AI/ML Overview

    The document describes the Edma Synthetic Nitrile Examination Gloves (K211540) and their acceptance criteria through non-clinical testing.

    Here's the breakdown of the requested information:

    1. Table of acceptance criteria and the reported device performance:

    Test MethodPurposeAcceptance CriteriaReported Device Performance
    ASTM D6319Physical DimensionsLength: ≥230mm; Width (M: 95±10, L: 110±10, XL: 120±10); Thickness (Finger: ≥0.08mm, Palm: ≥0.08mm)Length: >230mm; Width (M: 96-99, L: 106-109, XL: 114-118); Thickness (Finger: 0.08-0.13mm, Palm: 0.08-0.09mm). Pass
    ASTM D5151WatertightnessMeet the requirements of ASTM D5151 AQL 2.50/125 leaks. Pass
    ASTM D6124Powder ContentMeet the requirements of ASTM D6124
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