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Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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, Clear (Non-colored) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).

This document is a 510(k) Summary for medical gloves (Powder-Free Vinyl Patient Examination Gloves, Clear (Non-colored)). It does not describe an AI/ML device but rather a physical medical device. Therefore, much of the requested information regarding AI/ML device evaluation is not applicable.

However, I can extract information related to the acceptance criteria and the "study" (which in this case refers to non-clinical testing against standards) that proves the device meets these criteria, as presented in the document for this specific medical device.

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 each individual criterion (e.g., number of gloves tested for pinholes, tensile strength, etc.). It refers to meeting the requirements of specific ASTM standards. These standards typically define sampling plans that manufacturers must follow.

The provenance of the data is from the manufacturer's own testing in China, as the submitter is Zibo Yusheng Plastic Products Company Limited based in China. The testing would be considered prospective for the purpose of demonstrating conformance to standards for this 510(k) submission.

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

This information is not applicable. The "ground truth" for a physical medical device like a patient examination glove is established by adherence to recognized voluntary consensus standards (like ASTM standards) and FDA regulations. It does not involve expert consensus in the same way an AI/ML diagnostic device would. Performance is measured objectively against specified physical and chemical requirements.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation involves objective measurement against predefined standard specifications rather than interpretive or subjective assessments requiring adjudication.

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

This is not applicable for a physical medical device like an examination glove. MRMC studies are relevant for diagnostic AI/ML systems where human interpretation plays a role.

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

This is not applicable as the device is not an algorithm or AI/ML system.

7. The Type of Ground Truth Used

The ground truth used for this device's evaluation is defined by:

• Voluntary Consensus Standards: Specifically, ASTM D5250-06 (Reaffirmation 2011) for vinyl patient examination gloves, ASTM D5151-06 (Reapproved 2011) for detection of holes, and ASTM D6124-06 (Reaffirmation 2011) for residual powder.
• FDA Regulations: 21 CFR 800.20 (for freedom from pinholes).
• International Standards for Biocompatibility: ISO 10993-10 Third Edition 2010-08-01 for skin irritation and sensitization.

These standards and regulations establish the objective criteria (e.g., minimum tensile strength, maximum allowable pinholes) that the device must meet.

8. The Sample Size for the Training Set

This information is not applicable. There is no concept of a "training set" for physical medical devices like these gloves in the context of an AI/ML model. Manufacturers conduct process validation and quality control measures during manufacturing, but these are distinct from AI/ML training.

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

This is not applicable, as there is no "training set" in the AI/ML sense for this device. The manufacturer's internal quality systems and adherence to good manufacturing practices ensure consistent product quality, relying on the established performance standards mentioned above.

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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)

Patient Vinyl Examination Gloves, Yellow, Powder free, Non-Sterile

This document is a 510(k) premarket notification letter from the FDA regarding Patient Vinyl Examination Gloves. It primarily addresses regulatory approval and does NOT contain information about the acceptance criteria or a study that proves the device meets specific performance criteria.

Therefore, I cannot provide the requested information from the provided text.

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