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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, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00c4

Here's a breakdown of the acceptance criteria and study information for the device based on the provided text:

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 size for specific tests, nor does it specify the country of origin or whether the data was retrospective or prospective for the non-clinical tests. It refers to compliance with ASTM and ISO standards, which typically involve specific sample sizes outlined within those standards for each test (e.g., a certain number of gloves for physical property testing or a certain number of animals for biocompatibility).

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This device is a patient examination glove, and the acceptance criteria are based on technical performance standards and biocompatibility, not on expert interpretation of medical images or data requiring ground truth establishment by human experts.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective measurements against established technical standards, not subjective assessments requiring adjudication.

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

Not applicable. This is a medical device (patient examination glove), not an AI-assisted diagnostic or imaging system. Therefore, an MRMC study and the concept of human readers improving with AI assistance are irrelevant.

6. Standalone (Algorithm Only) Performance

Not applicable. There is no algorithm involved in the performance of a patient examination glove.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is based on established industry standards and regulatory requirements:

• ASTM Standard D 5250-00e4: This standard defines the specifications for vinyl patient examination gloves, covering dimensions, physical properties (e.g., tensile strength, elongation), and powder residual limits.
• 21 CFR 800.20: This U.S. FDA regulation specifies the leakage test (freedom from pinholes) for medical gloves.
• ASTM D6124-01 / ISO10993-10: These standards relate to biocompatibility testing, specifically primary skin irritation and dermal sensitization.

8. Sample Size for the Training Set

Not applicable. This device does not involve a "training set" as it's not an AI/machine learning product. The manufacturing process of gloves is subject to quality control, and units are sampled for testing against standards as part of a batch release, but this is not a "training set" in the context of AI.

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

Not applicable, as there is no "training set" in the context of this device. The standards themselves (ASTM, 21 CFR, ISO) are independently established through scientific consensus and regulatory processes to define acceptable performance for medical gloves.

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