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Powder free vinyl patient examination glove 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 vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

This is a submission for a patient examination glove, which is a Class I medical device. The information provided is primarily related to non-clinical performance testing against established standards, and therefore, many of the requested categories regarding clinical studies, expert adjudication, and AI performance are not applicable.

Here's the breakdown of the available information:

Acceptance Criteria and Device Performance

Study Demonstrating Device Meets Acceptance Criteria

The device's performance against the acceptance criteria is demonstrated through a series of non-clinical tests. The submission states that the "Powder free vinyl patient examination gloves, Clear (non-colored) meet requirements per ASTM D5250-06, per ASTM D6124-06, per 21 CFR 800.20 and FDA recognition number 2-87: AAMI / ANSI / ISO 10993-10:2002."

Specifics of the Study:

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

   • The document does not explicitly state the sample sizes used for each of the non-clinical tests (e.g., how many gloves were tested for pinholes, or how many animals for biocompatibility).
   • Data provenance is not specified beyond indicating compliance with international and US standards (ASTM, CFR, ISO). It implies these tests were conducted by the manufacturer or accredited labs to these standards. The country of origin of the manufacturer is China.

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

   • Not applicable. This device relies on standardized physical and chemical testing, not expert interpretation of results in a clinical setting.

3. Adjudication method for the test set:

   • Not applicable. Performance is determined by meeting objective physical and chemical thresholds defined in the referenced standards.

4. 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 a physical medical device (examination gloves), not an AI-powered diagnostic or assistive tool.

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

   • Not applicable, as this is not an algorithm or AI device.

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

   • The ground truth is based on standardized test methods and acceptance criteria defined by the referenced ASTM standards, 21 CFR regulations, and ISO standards for physical properties, chemical composition (powder residual), and biocompatibility.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of this type of non-clinical device testing.

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

   • Not applicable.

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