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Nitrile Powder Free Patient Examination Gloves, Coloured (Blue) 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.

Nitrile Powder Free Patient Examination Gloves that meets all of the requirements of ASTM standard D 6139-05

Here's a breakdown of the acceptance criteria and study information 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 explicitly state the specific sample sizes used for each test (e.g., how many gloves were tested for pinholes, or how many animals were used for biocompatibility tests). It only refers to compliance with the standards, which would implicitly define sample sizes within those standards.

The provenance of the data is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It is implied to be data collected to demonstrate compliance with the referenced ASTM standards and CFR regulations.

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

This information is not applicable and not provided in the document. The "ground truth" for glove testing is established by objective measurements against predefined criteria in the referenced standards (e.g., tensile strength, elongation, water leak test for pinholes, chemical analysis for powder residue, animal studies for biocompatibility). These are not expert interpretations requiring adjudication in the way medical imaging diagnosis would.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in human interpretation studies (e.g., radiology reads). For physical or chemical testing of medical devices like gloves, the assessment is based on direct measurement and meeting specified thresholds in standards, not subjective expert opinion.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. without AI Assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices where human reader performance is being evaluated. This document pertains to a physical medical device (examination gloves), not a diagnostic AI system.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable. This document describes the performance of a physical device (examination gloves), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by objective measurements and chemical/biological tests against the specific criteria and methodologies outlined in the referenced ASTM standards (D 6139-05, D 5250-06, D6124-06) and FDA regulations (21 CFR 800.20, ISO10993-10). Examples include:

• Dimensional measurements (e.g., length, width, thickness).
• Physical property tests (e.g., tensile strength, elongation at break).
• Water leak tests for freedom from pinholes.
• Chemical analysis to quantify powder residue.
• Animal studies (rabbits for primary skin irritation, guinea pigs for dermal sensitization) for biocompatibility.

8. The Sample Size for the Training Set

This is not applicable. This device is a physical product, not a software or AI model that requires a training set.

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

This is not applicable. As stated above, this device does not involve a training set.

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