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Powder Free Vinyl Patient Examination Gloves,White Color is a non-sterile 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 Color are disposable devices which made of PVC material ,intended for medical purpose that worn on examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 e1.

The provided text describes a medical device called "Powder Free Vinyl Patient Examination Gloves, White Color" and its substantial equivalence to a predicate device. This is a Class I device and the submission focuses on non-clinical performance criteria based on established standards.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

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 each specific test (e.g., how many gloves were tested for pinholes, physical properties, etc.). However, it refers to compliance with established standards (ASTM D 5250-06 e1, ASTM D6124-06, 21 CFR 800.20, and ISO 10993-10). These standards would define the required sample sizes for testing.

The data provenance is from non-clinical testing conducted by the manufacturer, Suqian Ruijiang Medical Supplies Co., Ltd. The document does not specify the country of origin of the raw data, but the manufacturer is based in Suqian, Jiangsu, China. The testing described is retrospective in the sense that the results were generated prior to the 510(k) submission to demonstrate compliance with existing standards.

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 submission. The "ground truth" for this Class I medical device (patient examination gloves) is established by adherence to recognized regulatory standards and specifications, rather than expert consensus on complex diagnostic interpretations. The standards themselves define the acceptable parameters for glove performance.

4. Adjudication Method for the Test Set

This information is not applicable to this submission. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or other subjective assessments. For this device, the "judgement" is determined by whether the test results meet the objective, quantitative criteria outlined in the referenced ASTM standards and FDA regulations.

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 information is not applicable. This submission is for a basic medical device (examination gloves) and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC study is not relevant.

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

This information is not applicable. This device is a physical product (gloves) and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The ground truth used is based on established regulatory standards and objective test methods. Specifically:

• ASTM D 5250-06 e1: Standard for Vinyl Patient Examination Gloves. This standard specifies requirements for dimensions, physical properties (tensile strength, elongation), and other performance characteristics.
• ASTM D6124-06: Standard Test Method for Residual Powder on Medical Gloves. This standard dictates the acceptable levels of powder residue.
• 21 CFR 800.20: This FDA regulation pertains to the freedom from pinholes (water leak test).
• ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization. This standard sets the criteria for biocompatibility testing.

The "ground truth" is that the device must meet the specifications and pass the tests outlined in these standards.

8. The Sample Size for the Training Set

This information is not applicable. This submission is for a physical medical device. The concept of a "training set" is relevant to machine learning algorithms, which are not involved here.

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

This information is not applicable for the same reasons as #8.

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