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Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.

The subject device is disposable medical PVC gloves that made from PVC compound, Clear (non-colored), powder free and nonsterile. The device meets the specifications in ASTM D5250-06(Reapproved 2015) Standard specification for poly (vinyl chloride) gloves for medical application.

This document is a 510(k) Premarket Notification summary for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". It describes the device, its intended use, and the studies conducted to demonstrate substantial equivalence to a predicate device.

Here's an analysis 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 the data provenance:

The document does not explicitly state the specific sample sizes for each non-clinical test (e.g., number of gloves tested for dimensions, physical properties, pinholes). However, the tests are based on recognized standards (ASTM, ISO), which typically specify sample sizes or sampling plans (e.g., AQL levels).

• Data Provenance: The studies are non-clinical (laboratory/bench testing, and animal studies for biocompatibility). The document does not specify the country of origin of the test data but implies it was conducted by or for the manufacturer. All tests are retrospective, meaning they were performed on already manufactured product or materials to demonstrate compliance with standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable to this type of device and study. The "ground truth" for non-clinical performance and biocompatibility relies on objective measurements according to standardized test methods, not expert consensus or clinical interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. This is not a study involving human subjective assessment where adjudication would be necessary. The results are objective measurements from laboratory tests.

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:

Not applicable. This device is a medical glove, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and AI assistance are irrelevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a medical glove and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance of these gloves is defined by the acceptance criteria specified in internationally recognized standards (ASTM and ISO). These standards establish objective parameters and methods for evaluating physical properties (dimensions, tensile strength, elongation), integrity (pinholes), material properties (powder residual), and biological safety (biocompatibility).

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning algorithm, so there is no concept of a "training set."

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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