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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(Reaffirmation 2011).

The provided text describes the 510(k) summary for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)" manufactured by Geenli Plastic Co., Ltd. It outlines the device's characteristics and its substantial equivalence to a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is compared against ASTM standards and FDA requirements. The text explicitly states that the Subject Device (Geenli's gloves) meets these standards.

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

• Sample Size: The document does not specify the precise sample size used for the non-clinical tests (e.g., how many gloves were tested for holes, powder residue, or biocompatibility). It simply states that the device "meets requirements per ASTM D5250-06(Reaffirmation 2011), per ASTM D6124-06(Reaffirmation 2011), per 21 CFR 800.20 and ISO10993-10: 2006 third edition 2010-08-01." These standards themselves would typically define the sampling plans and acceptable quality levels (AQLs) for testing.
• Data Provenance: The document does not explicitly state the country of origin for the test data, nor whether the data was retrospective or prospective. It is implied to be prospective testing conducted by the manufacturer to demonstrate compliance with standards.

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

This section is not applicable as the device is a medical glove, and the acceptance criteria are based on objective physical, chemical, and biological performance standards (e.g., hole detection, tensile strength, biocompatibility), not on expert subjective interpretation or ground truth derived from expert consensus.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., medical imaging) where there might be disagreement among reviewers on a specific finding. The tests for these gloves are objective physical and chemical tests against defined standards.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human readers interpreting results (e.g., radiologists reading images). This device is a medical glove, whose performance is assessed through objective criteria.

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

This question is not applicable. A standalone performance evaluation (without human-in-the-loop) is relevant for AI algorithms or diagnostic systems. This device is a physical medical glove.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is based on objective, standardized test results against established national and international standards. Specifically:

• Physical properties (e.g., integrity, dimensions) are evaluated against ASTM D5250 and D5151.
• Chemical properties (e.g., powder residue) are evaluated against ASTM D6124.
• Biocompatibility is evaluated against ISO 10993-10.
• Manufacturing quality and AQL for pinholes are evaluated against 21 CFR 800.20.

There is no "expert consensus," "pathology," or "outcomes data" in the typical sense of a diagnostic or therapeutic device. The ground truth is the measured compliance with the specified performance standards.

8. The Sample Size for the Training Set

This section is not applicable. The concept of a "training set" refers to data used to train machine learning models. This device is a physical medical glove and does not involve an algorithm or AI that requires training data.

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

This section is not applicable for the same reasons as point 8.

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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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