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Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.

The provided document is a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". This is a medical device, but it is not an AI/ML powered device, nor is it a device that requires image analysis or complex diagnostic algorithms. Therefore, many of the requested criteria such as "test set", "training set", "experts", "ground truth", "adjudication method", and "MRMC comparative effectiveness study" are not applicable to this type of regulatory submission. The submission is for a physical product, a glove, and its performance is assessed against physical and chemical standards.

Here's a breakdown of the applicable information:

1. Table of Acceptance Criteria and 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)

This information is not provided in a detailed manner that specifies exact sample sizes for each test. The document states that the device "meets requirements per ASTM D5250-06 e1, per ASTM D6124-06, per 21 CFR 800.20 and FDA recognition number 2-87: AAMI / ANSI / ISO 10993-10:2002." These standards inherently define testing methodologies and sample sizes (e.g., AQL levels for pinhole tests), but the specific results for the exact number of gloves tested are not enumerated in this summary. The manufacturer is based in China. The provenance of the data is the tests conducted by the manufacturer to meet these standards.

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)

Not applicable. The ground truth for this device (a glove) is established by adherence to physical, chemical, and biological performance standards, not by expert interpretation of images or other subjective data. Testing personnel performing the standard tests would be technicians qualified to conduct those specific tests.

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

Not applicable. This is not a diagnostic device requiring adjudication of results from multiple readers. The results are determined by objective tests against established 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

Not applicable. This is not an AI-powered device.

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

Not applicable. This is not an algorithm.

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

The ground truth is based on established industry standards and regulations for medical gloves, including:

• ASTM standard D 5250-06 e1 (for dimensions and physical properties)
• 21 CFR 800.20 (for freedom from pinholes)
• ASTM standard D6124-06 (for powder residual)
• AAMI / ANSI / ISO 10993-10:2002 (for biocompatibility - primary skin irritation and dermal sensitization)

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable. There is no "training set" for this type of device.

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