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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 5250-06.

The provided text describes the acceptance criteria and the study demonstrating that a medical device, specifically "Powder Free Vinyl Patient Examination Gloves, Clear(non-colored)," meets these criteria.

Here's the breakdown of the information requested:

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 testing each characteristic. However, it indicates that the tests were performed according to specified ASTM standards, 21 CFR, and ISO standards, which would typically define the required sample sizes for such tests.

The data provenance is implied to be from manufacturers in China (RAYU PLASTIC PRODUCTS LIMITED is based in China). The nature of these tests (mechanical, chemical, biological) suggests laboratory testing, which is generally prospective for product development and regulatory submission.

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

This type of information is not applicable to this device. The "ground truth" for these tests (e.g., proper dimensions, lack of pinholes, powder residue levels, biocompatibility) is established through objective, standardized laboratory measurements and scientific protocols, not through expert consensus or clinical interpretation of images/cases.

4. Adjudication Method for the Test Set

This is not applicable to this device. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation or subjective assessment (e.g., radiology studies). For manufacturing and materials testing, results are objectively measured and compared against predefined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. These types of studies are relevant for diagnostic devices where human readers interpret medical images or data, and the goal is to assess the impact of AI on their performance. This device is a patient examination glove, and its performance is evaluated by meeting technical and biocompatibility standards, not through human reading of cases.

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

No, a standalone "algorithm only" performance study was not done. This concept applies to AI algorithms that can perform a task (e.g., disease detection) without human intervention. This document describes the testing of a physical medical device (gloves), not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this device's testing is based on objective measurements against established industry and regulatory standards. These include:

• ASTM (American Society for Testing and Materials) standards: For dimensions, physical properties, and powder residual.
• 21 CFR (Code of Federal Regulations) 800.20: For freedom from pinholes.
• ISO 10993-10: For biocompatibility (Primary Skin Irritation and Dermal Sensitization).
• D6124-06: For powder residual.

These standards define specific parameters and acceptable ranges, and the device's performance is measured directly against them.

8. The Sample Size for the Training Set

This information is not applicable. This document describes the testing of a conventionally manufactured medical device (gloves), not the development or training of an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

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

This information is not applicable for the reasons stated in point 8.

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