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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.

Here's a breakdown of the acceptance criteria and study information based on the provided text, using the structure you requested:

Acceptance Criteria and Device Performance

1. A table of acceptance criteria and the reported device performance:

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

• Sample Size: Not explicitly stated for each test, but the device was tested against the requirements of ASTM standard D 5250-06, ASTM standard D6124-01, 21 CFR 800.20, and ISO10993-10. These standards would specify their own sampling plans.
• Data Provenance: Not explicitly stated, but given the manufacturer's location (Tangshan, China), the testing was likely conducted in China or by a certified laboratory supporting the Chinese manufacturer. The data is retrospective as it was conducted to demonstrate substantial equivalence for premarket notification.

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

• Number of Experts: Not applicable. The ground truth for this device (patient examination gloves) is established through standardized physical, chemical, and biological testing as per the listed ASTM and FDA regulations, not through expert consensus on qualitative data.
• Qualifications of Experts: Not applicable as per the above.

4. Adjudication method for the test set:

• Adjudication method: Not applicable. The "ground truth" for this device is based on quantifiable measurements against pre-defined thresholds in industry standards and regulations, rather than subjective interpretations requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance:

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a disposable medical glove, and its performance is evaluated through physical, chemical, and biological testing, not through human reader interpretation or AI assistance.

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

• Standalone Performance: Not applicable. This device is a physical medical product (gloves), not an algorithm or an AI-powered system. Its performance is inherent to its material properties and manufacturing.

7. The type of ground truth used:

• Type of Ground Truth: The ground truth for this device is based on standardized measurements and testing results against established criteria outlined in:
  • ASTM standard D 5250-06 (for dimensions and physical properties)
  • ASTM standard D6124-01 (for powder residual)
  • 21 CFR 800.20 (for freedom from pinholes/waterleak test AQL)
  • ISO10993-10 (for biocompatibility, specifically primary skin irritation and dermal sensitization).

8. The sample size for the training set:

• Sample Size (Training Set): Not applicable for this type of device. There isn't a "training set" in the context of data-driven machine learning for a physical product like a glove. The testing performed is to ensure the product meets specifications.

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

• Ground Truth (Training Set): Not applicable. As there is no training set for an AI algorithm, there is no ground truth to establish in that context. The "ground truth" for the device's characteristics is defined by the technical specifications and performance limits set forth in the referenced ASTM standards and FDA regulations.

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