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510(k) Data Aggregation

    K Number
    K211666
    Date Cleared
    2022-01-09

    (222 days)

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

    Powder Free Nitrile Examination Gloves, Blue Chemotest

    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 on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

    Device Description

    It is the powder-free variation of the class I latex patient examination gloves made by on-line polymer-coating and mild on-line chlorination process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder.

    AI/ML Overview

    This is a 510(k) summary for a medical device (Powder Free Nitrile Examination Gloves, Blue, Chemotest), not an AI/ML device. Therefore, the sections regarding AI/ML device assessment criteria (such as sample size for test/training set, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable.

    The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing.

    Here's the relevant information extrapolated from the document regarding acceptance criteria and performance:

    1. Table of Acceptance Criteria and Reported Device Performance

    CharacteristicStandardAcceptance CriteriaReported Device Performance
    Freedom From HolesASTM D6319-19, ASTM D5151-19Inspection level G-I, AQL 2.5Pass
    DimensionASTM D6319-19Length, min. (mm): XSmall 220, Small 220, Medium 230, Large 230, XLarge 230Pass (Meets requirements for all sizes)
    Thickness, min. (mm): 0.05 (palm, finger)Pass (Meets 0.05mm min)
    Width, ± 10 (mm): XSmall 70, Small 80, Medium 95, Large 110, XLarge 120Pass (Meets requirements for all sizes)
    Physical Properties (Before Aging)ASTM D6319-19Tensile Strength: 14 MPa min.Pass (Meets 14MPa min.)
    Ultimate Elongation: 500 % min.Pass (Meets 500% min.)
    Physical Properties (After Accelerated Aging)ASTM D6319-19Tensile Strength: 14 MPa min.Pass (Meets 14MPa min.)
    Ultimate Elongation: 400 % min.Pass (Meets 400% min.)
    Residual Powder ContentASTM D6319-19, ASTM D6124-06Not more than 2 mg per glovePass (Meets 2mg/glove max.)
    Biocompatibility - Primary Skin Irritation TestISO 10993-10No IrritationNo irritant response
    Biocompatibility - Skin Sensitization TestISO 10993-10No IrritationNo skin sensitization effect
    Biocompatibility - In Vitro Cytotoxicity TestISO 10993-5:2009(No specific numerical criteria, evaluated for reactivity)Moderate cytotoxicity reactivity at 6.0 cm²/mL; No cytotoxicity reactivity at 3.0 cm²/mL
    Biocompatibility - Acute Systemic ToxicityISO 10993-11(No specific numerical criteria, evaluated for adverse biological reactions)No adverse biological reaction
    Chemotherapy Drugs Permeation TimeASTM D6978-05(Breakthrough detection time in minutes per drug)Carmustine (BCNU): 22.6 min (WARNING: Not recommended for use)
    Cisplatin: >240 min
    Cyclophosphamide (Cytoxan): >240 min
    Dacarbazine: >240 min
    Doxorubicin HCL: >240 min
    Etoposide: >240 min
    Fluorouracil: >240 min
    Ifosfamide: >240 min
    Mitoxantrone: >240 min
    Paclitaxel: >240 min
    Thio Tepa: 43.9 min (WARNING: Not recommended for use)
    Vincristine Sulfate: >240 min

    2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    The document does not explicitly state the sample sizes for each non-clinical test (e.g., number of gloves tested for dimensions, holes, or physical properties). However, it implies that the testing was conducted according to the specified ASTM and ISO standards, which would dictate appropriate sample sizes for each test method.

    The data provenance is not explicitly stated in terms of country of origin of the testing data itself, but the applicant is Careglove Global SDN BHD from Malaysia. The studies are non-clinical, laboratory-based tests.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    Not applicable, as this is for a physical medical device (examination gloves) and not an AI/ML diagnostic or predictive device requiring ground truth from human experts. The "truth" is established by physical measurement against standard specifications.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    Not applicable. This concept applies primarily to AI/ML clinical studies where human readers might adjudicate discrepancies or define ground truth. For physical device testing, results are measured and compared against established standards.

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    Not applicable, as this is not an AI/ML device.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    Not applicable, as this is not an AI/ML device.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

    The "ground truth" or reference values for device performance are defined by recognized international and national standards:

    • ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application)
    • ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves)
    • ASTM D6124-06 (Standard Test Method for Residue on Medical Gloves)
    • ASTM D6978-05 (Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs)
    • ISO 10993-10 (Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization)
    • ISO 10993-5:2009 (Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity)
    • ISO 10993-11 (Biological evaluation of medical devices – Part 11: Tests for systemic toxicity)

    The device's performance is compared directly to the specifications outlined in these standards.

    8. The sample size for the training set

    Not applicable, as this is not an AI/ML device and therefore does not have a "training set."

    9. How the ground truth for the training set was established

    Not applicable, as this is not an AI/ML device and therefore does not have a "training set" with established ground truth.

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