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Powder Free Vinyl Patient Examination Gloves, Light Yellow 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, Light Yellow Color that meets all of the requirements of ASTM standard D 5250-06e1.

The provided text describes the acceptance criteria and performance of Powder Free Vinyl Patient Examination Gloves, Light Yellow Color, as submitted in a 510(k) summary (K093570) to the FDA. The study presented a non-clinical evaluation to demonstrate substantial equivalence to a predicate device.

Here's the breakdown of the acceptance criteria and study information:

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 size used for the test set for each characteristic. However, it indicates that the tests were performed according to specified ASTM and CFR standards, which would inherently include appropriate sample size requirements for those tests. The data provenance is not specified beyond the tests being conducted for the Jiangsu Jaysun Glove Co.,Ltd., located in China. The study is a non-clinical evaluation.

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

This section is not applicable as the device is a medical glove, and the evaluation involves objective performance testing against established physical and chemical standards, not expert interpretation of outputs like in imaging or diagnostic AI.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as point 3. The evaluation relies on objective measurements against predefined standards, not subjective assessment requiring adjudication.

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

This section is not applicable. The device is a medical glove, not an AI system. Therefore, an MRMC study and the concept of human readers improving with or without AI assistance are irrelevant.

6. Standalone (Algorithm Only) Performance Study

This section is not applicable. The device is a medical glove. The evaluation focuses on the physical and biological properties of the glove itself, not on an algorithm's performance.

7. Type of Ground Truth Used

The ground truth used for the device's performance evaluation is based on established industry and regulatory standards. These include:

• ASTM standard D 5250-06e1 (for dimensions and physical properties)
• 21 CFR 800.20 (for freedom from pinholes, commonly referred to as the "waterleak test" for AQL)
• ASTM standard D 6124-06 (for powder residual)
• AAMI / ANSI / ISO 10993-10 (for biocompatibility, specifically primary skin irritation and dermal sensitization)

These standards define the acceptable range or threshold for each characteristic.

8. Sample Size for the Training Set

This information is not applicable. The device is a medical glove, and its evaluation does not involve a "training set" in the context of machine learning or AI.

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

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

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