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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 5250-00ed

Here's a breakdown of the acceptance criteria and study information for the Zibo Hongye Shangqin Plastic & Rubber Co., Ltd. Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored), based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

Study Details

This device is a Class I medical device (patient examination glove), and the submission primarily relies on non-clinical testing to demonstrate substantial equivalence to a predicate device (FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves, K032908). Clinical data was explicitly stated as not needed for this type of device.

Here's a breakdown of the study information based on the provided text:

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

   • The document does not specify the exact sample sizes used for the non-clinical tests (Dimension, Physical Properties, Freedom from pinholes, Powder Residual, Biocompatibility).
   • Data Provenance: The document does not explicitly state the country of origin for the data or whether the tests were retrospective or prospective. Given that the manufacturer is based in China, it's highly probable the testing was conducted there, directly by or on behalf of the manufacturer, and would be considered prospective for the purpose of this submission.

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

   • This information is not applicable as the "ground truth" for these performance criteria is established through objective laboratory testing against established material standards (ASTM, CFR). It does not involve expert interpretation or consensus in the typical sense of a clinical diagnostic study.

3. Adjudication method for the test set:

   • Not applicable. As the "ground truth" is based on objective laboratory testing against material standards, there is no need for expert adjudication.

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:

   • No, an MRMC comparative effectiveness study was not done. This device is a patient examination glove and does not involve AI or human interpretation of medical images/data in a diagnostic context.

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

   • No, a standalone algorithm performance study was not done. This device is a physical medical product (glove), not an algorithm or software.

6. The type of ground truth used:

   • The "ground truth" (or reference standard) is based on established industry standards and regulations:
     • ASTM standard D 5250-00e4 (for Dimension, Physical Properties, Powder Residual)
     • 21 CFR 800.20 (for Freedom from pinholes/waterleak test AQL)
     • ISO10993-10 (for Biocompatibility, specifically Primary Skin Irritation and Dermal Sensitization)
     • ASTM D6124-01 (also related to powder residual or other physical properties)

7. The sample size for the training set:

   • Not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set.

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

   • Not applicable. As no training set was used, no ground truth needed to be established for it.

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