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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 (white, yellow) that meets all of the requirements of ASTM standard D 5250-0084.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is stated and noting areas where the information is not present:

Acceptance Criteria and Device Performance

Study Information

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

   • Sample size: Not explicitly stated. The document refers to meeting standards (ASTM, FDA) which would imply a defined sample size within those standards, but the specific quantity tested for each characteristic is not provided in this summary.
   • Data provenance: Not explicitly stated. The studies are non-clinical, likely conducted by the manufacturer or a third-party lab to demonstrate compliance with the referenced ASTM and ISO standards. The country of origin for the data (beyond the manufacturer's location in China) is not mentioned. It can be inferred that these are prospective tests performed on the device.

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

   • Not applicable/Not stated. For this type of device (patient examination gloves) and the tests conducted (physical and biocompatibility), "experts" in the sense of clinical reviewers establishing ground truth is not typically relevant. The ground truth for these tests is defined by the objective measurement criteria within the ASTM and ISO standards (e.g., maximum allowable pinholes, specific tensile strength values, observed skin reactions in animal models).

3. Adjudication method for the test set:

   • Not applicable/Not stated. Adjudication methods (like 2+1, 3+1) are typically used in studies where human interpretation of medical images or data is involved to establish a consensus ground truth. For the physical and biocompatibility testing of gloves, the results are objectively measured against predefined criteria in the 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 device is a physical patient examination glove, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies or AI assistance metrics are not relevant.

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

   • Not applicable. This device is a physical product, not an algorithm, so standalone performance in the context of AI is not relevant.

6. The type of ground truth used:

   • Objective Measurement/Standard Compliance: The ground truth for the performance criteria (dimensions, physical properties, freedom from pinholes, powder residual) is established by the specific, objective measurement criteria and threshold values defined within the ASTM standard D 5250-00e4 and 21 CFR 800.20.
   • Biological Response in Models: For biocompatibility, the ground truth is based on the observed biological responses in the animal models (rabbits for skin irritation, guinea pigs for dermal sensitization) according to the protocols outlined in ISO10993-10. "Passing" the test means the observed reaction falls below predefined thresholds for irritation or sensitization.

7. The sample size for the training set:

   • Not applicable. This device is a physical product, not a machine learning model, so there is no "training set."

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

   • Not applicable, as there is no training set for this device.

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