Search Results

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

Powder Free Latex Patient Examination Gloves, with Protein Content labeling Claim (Contains 50 Micrograms per dm- of Glove or Less of Water Extractable Protein), meets all of the requirements of ASTM D3578

This is a 510(k) premarket notification for a medical device (Powder Free Latex Patient Examination Gloves), not an AI/ML medical device. Therefore, many of the requested categories are not applicable.

Here's the information that can be extracted relevant to the provided text:

Acceptance Criteria and Device Performance

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):
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 test data, but the submitter is based in Malaysia. The testing would be prospective in nature, as it relates to testing the manufactured product before marketing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a physical product, not an AI/ML device requiring expert interpretation for ground truth. The "ground truth" is defined by the objective measurement adhering to industry standards (ASTM, ISO).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Testing involves objective measurements against established physical and chemical standards, not subjective expert adjudication.

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 is for a physical medical glove, not an AI/ML diagnostic or assistive device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is for a physical medical glove, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the device's performance is established by the international and national standards referenced (ASTM D 3578-10, ASTM D 5151-11, ASTM D 6124-11, ASTM D 5712-10, ISO 10993-10:2010). The device is deemed to meet these objective, pre-defined standards.

8. The sample size for the training set:
Not applicable. This is a physical product, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established:
Not applicable. This is a physical product, not an AI/ML algorithm.

Ask a specific question about this device