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510(k) Data Aggregation

    K Number
    K190942
    Date Cleared
    2020-01-07

    (272 days)

    Product Code
    Regulation Number
    880.6250
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    Disposable Powder Free Nitrile Examination Glove, Pink/Black Color

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

    The Nitrile Powder Free patient examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

    Device Description

    "Disposable Powder Free Nitrile Examination Glove, Pink Color" and "Disposable Powder Free Nitrile Examination Glove, Black Color" are patient examination gloves made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.

    AI/ML Overview

    This document is a 510(k) summary for a disposable powder-free nitrile examination glove, and as such, it focuses on demonstrating substantial equivalence to a predicate device based on bench testing. It does not describe an AI medical device, and therefore, many of the requested elements for AI/ML evaluation (such as sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance of an algorithm) are not applicable.

    However, I can extract the acceptance criteria and reported device performance from the provided text for the physical characteristics of the glove.

    1. Table of acceptance criteria and the reported device performance

    CharacteristicsAcceptance Criteria (Standard)Reported Device Performance
    DimensionASTM D6319-10 (Reapproved 2015)
    Length≥230mmComplies with ASTM D6319-10 (230mm min.)
    Width (X-Small)70 ± 10 mmComplies with ASTM D6319-10 (70 ± 10 mm)
    Width (Small)80 ± 10 mmComplies with ASTM D6319-10 (80 ± 10 mm)
    Width (Medium)95 ± 10 mmComplies with ASTM D6319-10 (95 ± 10 mm)
    Width (Large)110 ± 10 mmComplies with ASTM D6319-10 (110 ± 10 mm)
    Width (X-Large)120 ± 10 mmComplies with ASTM D6319-10 (120 ± 10 mm)
    Thickness (Finger tip)≥0.05mmComplies with ASTM D6319-10 (0.05mm min.)
    Thickness (Palm)≥0.05mmComplies with ASTM D6319-10 (0.05mm min.)
    Physical PropertiesASTM D6319-10 (Reapproved 2015)
    Tensile strength (Before aging)≥14MPa14 MPa, min.
    Tensile strength (After aging)≥14MPa14 MPa, min.
    Elongated rate (Before aging)≥500%500% min.
    Elongated rate (After aging)≥400%400% min.
    Freedom from pinholesPassed Standard Acceptance Criteria (21 CFR 800.20, ASTM D6319-10, ASTM D5151-06)In accordance with ASTM D6319-10 and ASTM D5151-06, G-1, AQL 2.5
    Powder Residual
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