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The Disposable Vinyl Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl patient examination gloves. The subject device is clear. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is nonsterile.

The provided document is a 510(k) summary for a medical device called "Disposable Vinyl Examination Glove." It details the non-clinical testing performed to demonstrate that the device meets acceptance criteria and is substantially equivalent to a predicate device.

Here's the information broken down according to your request:

Acceptance Criteria and Reported Device Performance

Study Information to Prove Acceptance Criteria

1. Sample size used for the test set and the data provenance:

   • For the Watertightness Test (ASTM D5151), the reported result states "0/125 leaks," implying a sample size of 125 gloves were tested.
   • For other tests like physical dimensions (ASTM D5250), powder content (ASTM D6124), physical properties (ASTM D412), cytotoxicity (ISO 10993-5), irritation (ISO 10993-10), and sensitization (ISO 10993-10), the exact sample sizes are not explicitly stated in the provided summary. However, these tests would typically involve a statistically appropriate number of samples as defined by the respective ASTM and ISO standards.
   • Data Provenance: The document does not explicitly state the country of origin of the test data or whether it was retrospective or prospective. Given that the manufacturer is "Inner Mongolia Cureguard Medical Materials Co., Ltd." in China, it is highly probable that the testing was conducted in China. These tests are inherently prospective as they are performed specifically to evaluate the manufactured device against established standards.

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

   • This document describes non-clinical performance testing of a physical medical device (examination gloves). The "ground truth" for these tests is established by objective measurements and chemical/biological assays according to the specified ASTM and ISO standards, not by expert consensus or interpretation in the way one might assess an AI diagnostic algorithm. Therefore, the concept of "experts establishing ground truth" in the context of medical imaging or clinical diagnosis is not applicable here. The tests are performed by technicians following standard protocols.

3. Adjudication method for the test set:

   • Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation or subjective assessments. For the non-clinical, objective performance tests described, no adjudication method is relevant or mentioned. The results are quantitative measurements or pass/fail determinations based on predefined criteria in the standards.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, an MRMC comparative effectiveness study was not done. This device is a disposable vinyl examination glove, and the testing focuses on its physical, chemical, and biological properties, not on diagnostic accuracy requiring human reader interpretation with or without AI assistance.

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

   • This question is not applicable as the device is a physical examination glove, not an AI algorithm.

6. The type of ground truth used:

   • The "ground truth" for this device's performance is established by conformance to internationally recognized standards (ASTM D5250, D5151, D6124, D412, ISO 10993-5, ISO 10993-10). These standards define specific test methodologies and acceptance criteria based on objective measurement. For example, for watertightness, the ground truth is simply whether water leaks or not under specified conditions, as directly measured. For biocompatibility, it is the observed biological response to certain assays.

7. The sample size for the training set:

   • This concept is not applicable to the testing of a physical medical device like an examination glove. "Training set" refers to data used to train machine learning models. The tests performed are for product quality and safety validation, not model training.

8. How the ground truth for the training set was established:

   • This question is not applicable for the same reason as point 7.

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