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Powder free 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.

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

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text.

Based on the provided document, the device in question is "Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)". This summary is for a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than de novo clinical efficacy studies typical for novel devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the "Powder Free Vinyl Patient Examination Gloves" are defined by various standards and regulations. The reported device performance indicates compliance with these standards.

Note: The document explicitly states that the device "meets all of the requirements of ASTM standard D 5250-06."

2. Sample Size for the Test Set and Data Provenance

The document does not specify a distinct "test set" sample size in the context of a clinical trial or algorithm evaluation. The testing described is primarily non-clinical, focused on material and performance standards compliance. There is no information provided regarding the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and not provided. The ground truth for glove performance is established by objective measurements against quantitative physical, chemical, and biological standards, not by expert consensus on subjective assessments.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human observers or readers to resolve discrepancies in diagnoses or interpretations. This is not relevant to the non-clinical testing of patient examination gloves, and therefore, no such method is described or implied.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was conducted or reported. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to the assessment of patient examination gloves. The submission focuses on the device's inherent physical and biological properties.

6. Standalone (Algorithm Only) Performance Study

No standalone algorithm performance study was conducted. The device is a physical product (gloves), not an algorithm or an AI system. Therefore, this section is not applicable.

7. Type of Ground Truth Used

The ground truth used for demonstrating compliance is based on objective measurements against established industry standards and regulatory requirements.

• ASTM standards (D 5250-06, D6124-06): These provide specific test methods and acceptable ranges for dimensions, physical properties, and powder residue.
• 21 CFR 800.20: This federal regulation sets the acceptable quality level (AQL) for freedom from pinholes (water leak test).
• ISO10993-10: This international standard specifies tests for irritation and skin sensitization for medical devices.

8. Sample Size for the Training Set

This information is not applicable. The device is not an AI/ML algorithm that requires a training set. The tests performed are for product quality and safety, not for training a model.

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

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

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