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Powdered 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.

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

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:

Device: Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)

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 specific sample sizes for each test (e.g., how many gloves were tested for pinholes, how many rabbits/guinea pigs for biocompatibility). It references standards (ASTM D 5250-06, 21 CFR 800.20, ISO10993-10), which would dictate the sample sizes and testing methodologies.

The provenance of the data is implicit: it's generated by the submitter (Tangshan Dar Plastic & Rubber Products Co., Ltd.) to demonstrate compliance with internationally recognized standards for their product. It is a prospective assessment of their manufactured device against established criteria.

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

This type of device (patient examination gloves) does not typically involve expert review for its performance evaluation in the way a diagnostic imaging AI would. The "ground truth" for the performance criteria is established by the specified regulatory and industry standards themselves (ASTM D 5250-06, 21 CFR 800.20, ISO10993-10). These standards are developed by committees of experts in relevant fields (materials science, medical devices, toxicology, etc.), but the direct evaluation of this specific device's compliance is based on laboratory testing, not expert consensus on individual cases.

4. Adjudication Method for the Test Set

Not applicable. The performance is determined by objective laboratory testing against established physical, chemical, and biological criteria, not by human interpretation or adjudication of individual cases.

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

No. This device is a physical medical device (gloves), not a diagnostic algorithm where human readers would be "assisted" by AI. Therefore, an MRMC study is not relevant or performed.

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

No. This device is not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used is a combination of:

• Industry and Regulatory Standards: ASTM standard D 5250-06, 21 CFR 800.20, and ISO10993-10. These standards define the acceptable limits and methodologies for evaluating the product's performance.
• Laboratory Test Results: Objective measurements from physical, chemical, and biocompatibility tests explicitly designed to determine compliance with the aforementioned standards.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not a machine learning model. Therefore, there is no "training set." The manufacturing process for gloves is typically validated through quality control and adherence to Good Manufacturing Practices (GMP).

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

Not applicable, as there is no "training set" for this device.

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