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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 for the "Powder Free Vinyl Patient Examination Gloves, Clear(non-colored)" device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes used for testing each characteristic. The data provenance is not explicitly stated in terms of country of origin for the individual tests, but the device manufacturer is based in China. The studies appear to be prospective as they are conducted to demonstrate the device meets specific standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not provided in the document. For device testing (like these gloves), the "ground truth" is typically defined by the objective measurement adhering to the specified ASTM standards and CFR regulations, rather than expert consensus on subjective interpretations. For biocompatibility, the interpretation of results would be by qualified laboratory personnel following established protocols.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods like "2+1" or "3+1" are typically used in scenarios where multiple human readers are assessing subjective data (e.g., medical images) and their disagreements need to be resolved. For objective tests on physical properties of gloves, the results are typically directly measured against a standard, not adjudicated by a panel of experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to the assessment of physical properties or biocompatibility of examination gloves.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This device is a physical product (gloves), not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on objective measurements against established industry standards and regulatory requirements.

• ASTM standards (D 5250-06, D6124-01): These standards define the acceptable range for dimensions, physical properties, and powder residue. The ground truth is whether the measured values fall within these defined ranges.
• 21 CFR 800.20: This regulation defines the acceptable level of freedom from pinholes based on a water leak test. The ground truth is the pass/fail outcome of this test.
• ISO10993-10: This standard governs biocompatibility testing. The ground truth is the biological response observed (e.g., presence or absence of irritation/sensitization) as interpreted by standard toxicological protocols.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The development and testing of these gloves do not involve a "training set" in the context of machine learning or AI models. The gloves are manufactured and then tested against specified standards.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no "training set" for this type of device.

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