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

powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

Here's a breakdown of the acceptance criteria and study information for K101664, based on the provided text:

Reported Device: Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)

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 sample sizes used for testing each characteristic (e.g., number of gloves tested for pinholes or dimensions). It only states that the device "Meets" the specified standards.

The data provenance is not specified (e.g., country of origin, retrospective/prospective). This type of information is typically not included in a 510(k) summary for a Class I device like examination gloves, where performance standards are well-established.

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

This information is not applicable to this submission. For examination gloves, the "ground truth" is typically defined by adherence to published ASTM and FDA standards, which involve objective measurements and tests rather than expert interpretation of complex data.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies where there is subjective interpretation of data (e.g., medical imaging) which necessitates a consensus among experts. For objective measurements of glove properties, such a method is not relevant.

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 device is a physical product (examination gloves), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study is irrelevant.

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

This information is not applicable. As mentioned, this is a physical product, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this device is based on established objective standards and test methods. Specifically:

• ASTM D 5250-06': Standard specification for vinyl examination gloves for medical application, covering dimensions, physical properties, and powder amount.
• 21 CFR 800.20: FDA regulation for freedom from pinholes (water leak test).
• ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (for biocompatibility).

8. The Sample Size for the Training Set

This information is not applicable. "Training set" refers to data used to train an AI algorithm. This device is not an AI algorithm. The manufacturing process for gloves involves quality control checks, but this is distinct from an AI training set.

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

This information is not applicable. As this is not an AI device, there is no "training set" in the AI context, and thus no ground truth to be established for it. The product's compliance is directly assessed against the outlined standards.

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