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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.

This document describes the acceptance criteria and the study that proves the device meets those criteria for "Powder Free 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 specific sample sizes used for each test. However, the tests are conducted in accordance with referenced ASTM standards and FDA regulations, which would stipulate appropriate sample sizes for each type of test. The data provenance is not specified beyond being generated through testing against established standards. Given the context of a 510(k) submission, this data is typically generated prospectively during the device development and testing phase to demonstrate compliance.

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

This information is not applicable. The "ground truth" for the performance of these gloves is established by objective, standardized laboratory tests according to predefined specifications (e.g., ASTM standards, CFR regulations). It does not rely on expert consensus or adjudication in the medical diagnostic sense.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like "2+1" or "3+1" are relevant for subjective evaluations, typically in clinical studies or image interpretations. The performance of these gloves is assessed through objective, quantitative laboratory measurements against established standards, without the need for human adjudication of results in that manner.

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. The device is a medical glove, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to its evaluation.

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

This information is not applicable. The device is a physical medical glove and does not involve any algorithms or AI for its function.

7. The Type of Ground Truth Used

The ground truth used for evaluating the performance of the gloves is established by:

• Standardized Test Methods: Adherence to specific ASTM International standards (D 5250-06, D6124-06) for physical properties, dimensions, and powder residual.
• Regulatory Requirements: Compliance with 21 CFR 800.20 for freedom from pinholes.
• Biocompatibility Standards: Adherence to AAMI / ANSI / ISO 10993-10:2002 for primary skin irritation and dermal sensitization.

These standards and regulations define the objective criteria that the device must meet.

8. The Sample Size for the Training Set

This information is not applicable. The device is a medical glove and does not involve machine learning or AI, so there is no concept of a "training set" in this context.

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

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

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