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Powder-free yellow synthetic vinyl patient examination gloves 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 yellow synthetic vinyl patient examination gloves that meets all of the requirements of ASTM standard D 5250-06.

Here's an analysis of the provided 510(k) summary, focusing on the acceptance criteria and study details:

Acceptance Criteria and Device Performance

The device in question is a "Powder-free yellow synthetic vinyl patient examination glove." The summary indicates that the device's performance was evaluated against established standards for patient examination gloves.

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 specific sample sizes used for each test (Dimension, Physical Properties, Freedom from Pinhole, Powder Residual, Biocompatibility). These are typically specified in the referenced ASTM and ISO standards.

The data provenance is from non-clinical testing conducted by the manufacturer, ZHAOYANG PLASTIC CO., LTD. The country of origin of the testing data is not explicitly stated, but the manufacturer is based in China. The data is prospective in the sense that the manufacturer conducted these tests specifically to demonstrate compliance for this 510(k) submission.

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

This information is not applicable in this context. The "ground truth" for the performance of examination gloves is established by the specified standards (ASTM, FDA regulations, ISO). These standards define the objective criteria and test methods. There isn't a subjective "ground truth" established by experts in the same way there would be for image interpretation in a medical AI study. Compliance is determined by objective measurements against the defined standard limits.

4. Adjudication Method for the Test Set:

This is not applicable. As mentioned above, compliance with standards involves objective measurements, not subjective interpretation requiring adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation, especially AI-assisted diagnostics. For a patient examination glove, the "effectiveness" is determined by its conformity to physical, chemical, and biological safety standards, not by its diagnostic performance in conjunction with human readers.

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

This is not applicable. The device is a physical product (a glove), not a software algorithm. Therefore, the concept of "standalone algorithm performance" does not apply. The tests performed are on the physical properties and biological interactions of the glove itself.

7. The Type of Ground Truth Used:

The "ground truth" used is defined by:

• Standards specifications: ASTM standard D 5250-06 (for Dimension and Physical Properties).
• Regulatory limits: 21 CFR 800.20 (for Freedom from pinholes).
• Standards and regulatory limits: ASTM standard D 5250-06 and D6124-01 (for Powder Residual).
• International standards for biocompatibility: ISO10993-10 for Primary Skin Irritation and Dermal sensitization.

These standards provide objective, measurable criteria.

8. The Sample Size for the Training Set:

This is not applicable. As a physical product, this device does not involve a "training set" in the context of machine learning or AI models. The testing described is for the device's inherent properties and performance, not for developing or training an algorithm.

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

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

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