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Powder free vinyl 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.

powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00e4

Here's a breakdown of the acceptance criteria and the study information derived from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The device described is a medical device, specifically Powder-Free Vinyl Patient Examination Gloves, Clear (Non-Colored). The acceptance criteria for such a device primarily revolve around its physical properties, safety, and performance standards.

2. Sample Size for Test Set and Data Provenance:

• Sample Size for Test Set: The document does not explicitly state the sample size used for the performance tests. It refers to meeting the standards, implying that the number of samples tested was sufficient to demonstrate compliance with ASTM standards and FDA regulations for medical gloves.
• Data Provenance: The document does not specify the country of origin where the tests were conducted. The study is retrospective in nature, as it presents data and conclusions after the tests were performed to demonstrate compliance with pre-existing standards.

3. Number of Experts and Qualifications for Ground Truth:

This section is not applicable to this type of device and study. The "ground truth" for medical gloves is established by objective, standardized laboratory tests against recognized ASTM standards and FDA regulations, not by expert consensus or interpretation of specialized images or data.

4. Adjudication Method:

This section is not applicable for this type of device. Adjudication methods (like 2+1, 3+1) are used in studies where human interpretation is involved, such as reading medical images. For physical and chemical properties of a device like gloves, the results are definitive based on standardized tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This section is not applicable. MRMC studies are typically used in imaging or diagnostic device evaluations to assess how a device affects human reader performance. This study focuses on the inherent physical and biocompatibility properties of the gloves themselves, not on improving human performance in a diagnostic task.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

This section is not applicable. The device is a physical product (gloves) and does not involve any algorithms or artificial intelligence. Therefore, there is no "standalone" algorithmic performance to be evaluated.

7. Type of Ground Truth Used:

The ground truth used for this device's evaluation is primarily objective, standardized laboratory test results against established national and international standards (ASTM D5250-00e4, ASTM D6124-01, 21 CFR 800.20, and ISO10993-10). These standards define precise methodologies and acceptable ranges for characteristics like dimensions, physical properties, pinholes, powder residue, and biocompatibility.

8. Sample Size for Training Set:

This section is not applicable. The device is a physical product and does not involve any machine learning algorithms that would require a "training set."

9. How Ground Truth for Training Set Was Established:

This section is not applicable as there is no training set for this device.

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