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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 document describes the safety and effectiveness information for Powder Free Vinyl Patient Examination Gloves. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states the device "meets" or "passes" all defined acceptance criteria.

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

The document does not explicitly state the sample size used for the test set for each characteristic. It refers to compliance with standards like ASTM D 5250-06, ASTM D6124-06, 21 CFR 800.20, and ISO10993-10. These standards typically define sampling plans for testing.

Data Provenance: The testing was presumably conducted by the manufacturer, SHIJIAZHUANG HYLAND PLASTIC CO., LTD, which is located in China. The nature of the tests (e.g., physical property tests, biocompatibility tests) suggests these are prospective tests performed specifically for this submission.

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

This information is not applicable and not provided in the document. The device is a patient examination glove, and its performance is evaluated against engineering and biological standards, not through the subjective interpretation of medical images or case decisions by human experts. The "ground truth" for this type of device is defined by the objective measurements and pass/fail criteria of the specified standards.

4. Adjudication Method for the Test Set

Adjudication methods are not applicable for this type of device and testing. Performance is determined by objective measurements compared against pre-defined thresholds in established standards, not by expert consensus or dispute resolution.

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. This type of study is typically performed for diagnostic or screening devices where human interpretation is involved. This device is a medical accessory (glove) where performance is measured by physical and biological properties.

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

Not Applicable. This device is a physical product (glove), not a software algorithm. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

The "ground truth" used is based on objective engineering standards and biological testing standards. Specifically:

• ASTM standard D 5250-06 for dimensions, physical properties, and powder residual.
• 21 CFR 800.20 for freedom from pinholes.
• ASTM D6124-06 for powder residual.
• ISO 10993-10 for biocompatibility (Primary Skin Irritation and Dermal sensitization).
• FDA requirements for waterleak test.

8. The Sample Size for the Training Set

Not Applicable. This device is a physical product, not an AI/ML algorithm that requires a training set.

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

Not Applicable. As there is no training set for this device, there is no ground truth to be established for it.

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