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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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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 5250-00ed

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

The document describes a 510(k) premarket notification for "Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)." It focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes for each test (e.g., how many gloves were tested for pinholes, or how many animals were used for biocompatibility). The testing is non-clinical and conducted by the manufacturer, SUQIAN GREEN GLOVE CO.,LTD, located in China. The data would be considered prospective for the purpose of demonstrating equivalence for this submission.

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

This information is not applicable. The evaluations are based on established ASTM standards and CFR regulations, which define objective pass/fail criteria for physical and chemical properties. Biocompatibility tests rely on standard animal models and established methodologies, not expert consensus on individual cases.

4. Adjudication Method for the Test Set

This is not applicable. The evaluations are based on objective measurements against predefined standards, leaving no room for adjudication among experts.

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

No. This document does not mention any MRMC comparative effectiveness study. Such studies are typically relevant for diagnostic imaging devices where human interpretation is a key component.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This is not a software-based or AI-driven device. Its performance is entirely standalone in the sense that its physical and chemical properties are tested directly.

7. The Type of Ground Truth Used

The ground truth for the device's performance is based on established industry standards and regulations:

• ASTM standard D 5250-00e4 for dimensions, physical properties, and powder amount.
• 21 CFR 800.20 for freedom from pinholes (waterleak test).
• ISO10993-10 for biocompatibility (Primary Skin Irritation and Dermal Sensitization).

8. The Sample Size for the Training Set

This concept is not applicable to the device described. This is not an AI/ML device that requires a training set. The "training" for such a product involves adherence to manufacturing processes and quality control, not data-driven learning.

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

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

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