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Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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 5250-06e1.

This document describes the acceptance criteria and study for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)".

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the exact sample sizes used for each test. However, it indicates compliance with ASTM and ISO standards, which typically specify sample sizes for such tests.
The data provenance is from the manufacturer, PPP Medical and Safety Products Company Limited, located in Wuxi, Jiangsu, China. The studies appear to be retrospective, as they are part of a 510(k) submission for a device already manufactured and tested.

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

This information is not provided in the document. The standards themselves (ASTM, ISO, CFR) establish the methodologies and criteria for testing, and compliance is determined by laboratory results, not expert consensus on ground truth in a clinical sense.

4. Adjudication method for the test set:

Not applicable. The tests are based on objective measurements against predefined standards and regulations (e.g., ASTM standards for physical properties, 21 CFR for freedom from pinholes, AAMI/ANSI/ISO for biocompatibility). There is no mention of a human adjudication process beyond standard laboratory testing and reporting.

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:

Not applicable. This device is a medical glove, not an AI-assisted diagnostic or therapeutic device. Therefore, MRMC studies involving AI assistance for human readers are irrelevant to this product.

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

Not applicable. This is a physical medical device (gloves), not an algorithm or software. Its performance is evaluated through material and biological testing, not algorithmic performance.

7. The type of ground truth used:

The "ground truth" for this device's performance is established by the specified industry and regulatory standards. For example:

• Dimension and Physical Properties: The ground truth is defined by the measurable specifications outlined in ASTM standard D 5250-06 e1.
• Freedom from pinholes: The ground truth is the pass/fail criteria defined in 21 CFR 800.20 for water leak tests.
• Powder Residual: The ground truth is the quantitative limit specified in ASTM standard D 5250-06 e1 and D6124-06 (<2mg/glove).
• Biocompatibility: The ground truth is the absence of primary skin irritation or dermal sensitization as determined by the methodologies in AAMI / ANSI / ISO 10993-10 in animal models.

8. The sample size for the training set:

Not applicable. This device is a physical product and does not involve a "training set" in the context of machine learning or AI models. Its manufacturing process is subject to quality control, but not a data-driven training process.

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

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

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