Search Results

Powder free vinyl patient examination glove is a non-sterile 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.

The provided text describes the acceptance criteria and performance of a Non-sterile Powder Free Vinyl Patient Examination Gloves, Clear(non-colored) and the study that proves it meets those criteria.

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 (e.g. country of origin of the data, retrospective or prospective):

• Sample Size for Test Set: The document does not specify a distinct "test set" sample size in terms of the number of gloves tested for each characteristic. It refers to meeting the requirements of the standards (e.g., ASTM D 5250-06, 21 CFR 800.20, ISO10993-10), which would imply testing a sufficient number of samples as prescribed by those standards.
• Data Provenance: The studies were conducted to support a 510(k) submission from WANGDA PLASTIC CO., LTD, located in Kaifeng City, Henan, China. Therefore, the data likely originated from testing performed by or for this Chinese manufacturer. The studies are prospective in the sense that they were designed and executed to demonstrate compliance with specific standards for this device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• This information is not applicable to this type of device and study. The "ground truth" for glove performance is established by objective, standardized tests and measurements against pre-defined physical and chemical properties and biological responses, not by expert interpretation like in image analysis or clinical diagnosis. Biocompatibility tests (skin irritation, dermal sensitization) would be performed by qualified toxicologists or similar experts, but the document does not specify their number or qualifications beyond stating the tests were performed on rabbits and guinea pigs.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• This information is not applicable for this type of device. The evaluation of glove performance characteristics (dimensions, physical properties, pinholes, powder residual, biocompatibility) relies on objective measurement and observation against established thresholds within the specified standards, not subjective interpretation requiring an adjudication process.

5. 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 type of study is relevant for diagnostic devices that involve human interpretation of images or data, often with AI assistance. It is not applicable to the evaluation of physical and biocompatibility properties of examination gloves.

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

• Not applicable. This device is a physical product (examination gloves), not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept here.

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

• The "ground truth" for this device is based on objective, quantitative measurements and qualitative observations against the specifications set forth in recognized international standards and regulations. These include:
  • Dimensional measurements: Length, width, thickness as per ASTM standard D 5250-06.
  • Physical properties testing: Tensile strength, elongation at break as per ASTM standard D 5250-06.
  • Water leak test: To determine freedom from pinholes as per 21 CFR 800.20.
  • Powder residual measurement: As per ASTM D 5250-06 and D6124-06.
  • Biocompatibility assays: Observing biological responses (skin irritation, dermal sensitization) in animal models as per ISO10993-10 principles (implied by the tests performed).

8. The sample size for the training set:

• This information is not applicable. This device is not an AI/ML algorithm that requires a "training set." The performance evaluation relies on testing physical samples against pre-defined standards.

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

• This information is not applicable for the reason stated in point 8.

Ask a specific question about this device