Search Results

Powder Free Vinyl Patient Examination Gloves, White Color 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, White Color that meets all of the requirements of ASTM standard D 5250-06e1.

This document describes the acceptance criteria and performance for "Powder Free Vinyl Patient Examination Gloves, White Color".

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 sample sizes used for each specific test (Dimension, Physical Properties, Freedom from pinholes, Powder Residual, Biocompatibility). However, it implies testing was conducted according to the referenced ASTM standards and 21 CFR regulations, which would stipulate appropriate sample sizes for these types of tests.

The data provenance is not explicitly stated in terms of country of origin of the data or whether it was retrospective or prospective. Given the submitter's address is in China (Jiangsu Cureguard Gloves Co.,Ltd.), the testing was likely conducted in China. These would be prospective tests specifically performed for this submission.

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

This is not applicable as the device is a medical glove, and "ground truth" in the context of expert consensus, pathology, or outcomes data is not relevant for its mechanical and biological safety testing. The "ground truth" is established by the specifications of the referenced ASTM standards and regulatory requirements (21 CFR).

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

This is not applicable, as there is no subjective interpretation or need for expert adjudication in the objective physical and chemical tests performed on the gloves. The results are quantitative measurements against defined standards.

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:

This is not applicable. This device is a passive medical glove, not an AI-powered diagnostic or assistive device. Therefore, MRMC studies and AI assistance are not relevant.

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

This is not applicable. This device is a medical glove, not an algorithm or AI system.

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

The "ground truth" for this device's performance is based on objective measurement standards and regulatory criteria. These include:

• ASTM standard D 5250-06 e1 (for dimension, physical properties, powder residual)
• 21 CFR 800.20 (for freedom from pinholes)
• ASTM D6124-06 (for powder residual)
• AAMI / ANSI / ISO 10993-10 (for biocompatibility - primary skin irritation and dermal sensitization)

8. The sample size for the training set:

This is not applicable. The device is a medical glove, not a machine learning model, so there is no concept of a "training set".

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

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

Ask a specific question about this device