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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 5250-06.

Here's an analysis of the provided information regarding the device's acceptance criteria and the study demonstrating its compliance:

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 the various characteristics. However, for the biocompatibility tests:

• Primary Skin Irritation: "rabbits" (plural, but exact number not specified).
• Dermal Sensitization: "guinea pig" (singular or plural, but exact number not specified).

The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective).

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

This information is not applicable to the type of device and testing described. The "ground truth" for glove performance refers to meeting established engineering and biological standards, not expert interpretation of medical images or conditions.

4. Adjudication Method for the Test Set:

Not applicable. The testing involves objective measurements against established standards, not interpretation that would require adjudication.

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

No MRMC study was done, nor is it applicable to this type of medical device. This device is an examination glove, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This device is a physical product (gloves), not an algorithm or AI system.

7. Type of Ground Truth Used:

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

• ASTM standard D 5250-06 (for dimension, physical properties, powder amount)
• 21 CFR 800.20 (for freedom from pinholes)
• ISO 10993-10 (for biocompatibility, referred to generally in the nonclinical discussion)

8. Sample Size for the Training Set:

Not applicable. There is no mention or indication of a "training set" as this is not an AI/ML device. The testing described is for a manufactured product against specified performance standards.

9. How the Ground Truth for the Training Set was Established:

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

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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 performance of "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)" manufactured by SHIJIAZHUANG SAIL PLASTIC CO., LTD. This is a Class I medical device (K101840) and as such, the study conducted is primarily a non-clinical, bench testing study to demonstrate substantial equivalence to a predicate device and adherence to recognized standards.

Here's a breakdown of the requested information 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 specify the exact sample size used for each test. The studies are non-clinical, involving testing of the gloves themselves against established standards. The data provenance is implied to be from the manufacturer's own testing carried out to demonstrate compliance with the listed ASTM standards and FDA regulations. It is prospective testing designed to evaluate the product. The country of origin of the manufacturer is China.

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

This information is not applicable to this type of device and study. The "ground truth" for non-clinical testing of patient examination gloves is the specified standard (e.g., ASTM D 5250-06, 21 CFR 800.20). The tests are objective and quantitative (e.g., measuring dimensions, physical properties, pinholes, powder residue) or involve standardized biological assays. Expert consensus is not relevant here for establishing the ground truth of material properties.

4. Adjudication Method for the Test Set

This is not applicable. The tests are objective measurements against defined criteria in standards. There is no subjective assessment that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance

This is not applicable. This device is a patient examination glove, and the study is a non-clinical evaluation of its material properties and safety. AI assistance or human reader performance is not relevant.

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

This is not applicable. This device is not an algorithm or an AI product.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth used is standardized specifications and objective measurements as defined by:

• ASTM standard D 5250-06 (for Dimension, Physical Properties, Powder Residual)
• ASTM standard D6124-06 (for Powder Residual)
• 21 CFR 800.20 (for Freedom from pinholes)
• ISO 10993-10 (for Biocompatibility, specifically Primary Skin Irritation and Dermal Sensitization)

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of non-clinical testing for patient examination gloves. The evaluation focuses on the physical and biological properties of the device itself.

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

This is not applicable, as there is no training set for this type of device performance evaluation. The ground truth for evaluating the device's performance is established by the referenced national and international standards and regulations.

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