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

powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.

The device being described is "Powder Free Vinyl Patient Examination Gloves, Clear(non-colored)".

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each specific test (e.g., dimension, physical properties, pinholes, powder residual, biocompatibility studies). However, for these types of products and tests, standards like ASTM D5250-06e1 and 21 CFR 800.20 specify sampling plans and AQL (Acceptable Quality Level) for assessment.

The data provenance is not explicitly stated but can be inferred to be from prospective testing conducted by the manufacturer or a contracted lab to demonstrate compliance with the referenced standards. The country of origin of the data is not specified, but the manufacturer is based in China, suggesting the testing could have been performed there or by an accredited lab elsewhere.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable for this device and its testing. The "ground truth" for glove performance testing is established by objective, quantitative measurements according to the specified ASTM and ISO standards, not by expert consensus or qualitative assessment. For example, pinhole freedom is assessed by a water leak test, and powder residual is measured gravimetrically. Biocompatibility tests are standardized animal studies.

4. Adjudication Method for the Test Set

This is not applicable for this device and its testing. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or subjective assessment (e.g., medical image analysis) to resolve disagreements among readers. The tests performed for these gloves involve objective measurements against predefined criteria/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

This is not applicable. The device is a patient examination glove, not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or assessment of AI assistance for human readers was conducted or is relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The device is a physical product (glove), not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for evaluating the device's performance is based on objective, quantitative measurements and standardized test methodologies defined by the referenced ASTM (e.g., D5250-06e1, D6124-06), ISO (e.g., 10993-10), and CFR (21 CFR 800.20) standards. These standards prescribe how to conduct tests for dimensions, physical properties, freedom from pinholes, powder residual, and biocompatibility (primary skin irritation, dermal sensitization).

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This is not applicable. As there is no training set for a physical device like a glove, there is no ground truth to be established for it.

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