Search Results

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner.

The subject device is powder free synthetic Nitrile patient examination gloves. The subject device is blue. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The subject device is non-sterile.

The document describes the Edma Synthetic Nitrile Examination Gloves (K211540) and their acceptance criteria through non-clinical testing.

Here's the breakdown of the requested information:

1. 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 Watertightness Test (Detection of Holes): 125 (0/125 leaks reported). No specific sample sizes for other tests were explicitly stated within the document.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. The applicant is Edma Group, LLC, based in Phoenix, AZ, USA. The designated submission correspondent is Shanghai Truthful Information Technology Co., Ltd., based in Shanghai, China. This suggests testing could have been conducted in either location or by a third-party laboratory.

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 as the document describes the testing of a medical device (examination gloves) based on established international and national standards (ASTM, ISO). The "ground truth" here is compliance with these standards, measured through physical and biological tests, not through expert consensus on diagnostic interpretations.

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

This information is not applicable to this type of device testing. Adjudication methods are typically used in studies involving human interpretation (e.g., imaging studies) to resolve discrepancies among experts. The tests performed are objective laboratory measurements.

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 information is not applicable. This document evaluates physical characteristics and biocompatibility of examination gloves, not an AI-powered diagnostic device or a system involving human readers.

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

This information is not applicable. The device is an examination 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 compliance with established national and international standards and specifications (ASTM D6319, ASTM D6124, ASTM D5151, ISO 10993-5, ISO 10993-10). These standards define objective criteria (e.g., minimum tensile strength, maximum powder content, absence of holes, non-cytotoxicity) that the device must meet.

8. The sample size for the training set:

This information is not applicable. The device is an examination glove, not a machine learning model that requires a training set.

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

This information is not applicable for the same reason as point 8.

Ask a specific question about this device