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The Yuyuan, Latex Examination Glove is "a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." (21CFR 880.6250)

Natural rubber latex films form a barrier to body fluids and bloodborne pathogens. The latex 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. Natural rubber latex is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The leaching process removes traces of chemical accelerants that may be chemically irritating. The glove is manufactured in accordance with the reguirements of ASTM D3578-06 and ASTM D5151 requirements.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Device Performance

Note: The document states that the product "meets or exceeds acceptable scores" for nonclinical tests, and "satisfies the requirements for a safe and effective in powdered medical glove." Specific numerical results are not provided in this summary.

Study Details

The provided document describes non-clinical and clinical tests for a Yuyuan Powdered Latex Examination Glove. The studies are focused on demonstrating the glove's safety, effectiveness, and performance against established industry standards.

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

   • Test Set Sample Size: Not explicitly stated in the provided summary. The document mentions "data summaries indicate that the product meets or exceeds acceptable scores," implying that testing was conducted.
   • Data Provenance: Not explicitly stated. However, given that the manufacturer is Shandong Yuyuan Latex Gloves Co., Ltd in China, it's highly probable the studies were conducted in China. The summary does not specify if the studies were retrospective or prospective.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The studies described are for a medical device (examination gloves) and involve performance and safety testing against defined specifications, rather than expert-established ground truth for diagnostic accuracy.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This concept generally applies to studies involving human interpretation or expert review, which is not the primary focus of testing for examination gloves.

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 not an AI-powered device.

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

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the performance and safety tests appears to be objective measurements against established ASTM (American Society for Testing and Materials) standards (D3578-06 for performance, D5151-92 for water tightness, D5712-05 for protein) and common safety tests (rabbit irritation, guinea pig sensitization).

7. The sample size for the training set: Not applicable. This is not a machine learning model, so there is no "training set."

8. How the ground truth for the training set was established: Not applicable. There is no training set for this device.

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