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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.

Poly Vinyl Chloride (PVC) films form a barrier to prevent contamination between patient and examiner. The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. The Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.

This document is a 510(k) Pre-Market Notification for Powder Free Vinyl Patient Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a novel device meets specific acceptance criteria in a clinical setting.

Therefore, many of the requested sections are not applicable in this context. However, I can extract information related to the device's technical specifications and the non-clinical tests performed to ensure it meets established safety and performance standards for gloves.

Here's a breakdown of the relevant information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally defined by compliance with established ASTM and ISO standards for medical examination gloves. The reported device performance is presented as meeting these standards.

2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each individual non-clinical test (e.g., how many gloves were tested for pinholes, or how many rabbits for skin irritation). The data provenance is implied to be from the manufacturer (Shandong Shangwei Medical Products Co.,Ltd in China) through in-house testing or contracted labs, as these are non-clinical tests used for product compliance. The data is retrospective in the sense that these tests are performed on manufactured product samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The "ground truth" for these tests are objective measurements against established international and national standards (ASTM, ISO, CFR). There isn't a subjective "expert ground truth" for attributes like glove dimensions or tensile strength.

4. Adjudication method for the test set
Not applicable, as the tests involve objective measurements against predefined standards, not expert adjudication of subjective assessments.

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 is not an AI-powered diagnostic device. It is a medical examination glove.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This is not an AI-powered diagnostic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance of the gloves is based on objective measurements performed according to validated test methods defined in recognized international and national standards (e.g., ASTM D5250 for dimensions and physical properties, ASTM D5151 for pinholes, ASTM D6124 for powder residual, ISO 10993 for biocompatibility).

8. The sample size for the training set
Not applicable. This is a manufactured product, not an AI model requiring a training set.

9. How the ground truth for the training set was established
Not applicable.

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