Search Results

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.

The provided text describes the acceptance criteria and performance of "Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)" as part of a 510(k) premarket notification. Here's a breakdown of the requested information:

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 (e.g., how many gloves were tested for pinholes, dimensions, etc.). It generally refers to compliance with the standards, implying that the sample sizes and testing methodologies prescribed by these standards were followed.

The data provenance is not explicitly detailed with country of origin or retrospective/prospective status for each test. However, the submitter is based in China: Zhangjiagang All Fine Rubber-Plastic Products Co., Ltd., Shuanglong Road, Xizhang Town, Zhangjiagang City, Jiangsu, 215614, China. The testing would presumably have been conducted in China or by a laboratory recognized by the standards. These are non-clinical tests performed on the device itself.

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

This section is not applicable. The "ground truth" for the device's performance is established by adherence to technical standards (ASTM, CFR, ISO) and laboratory testing, not through expert consensus on medical images or clinical observations.

4. Adjudication Method for the Test Set

This section is not applicable as the evaluation involves meeting predefined technical specifications through laboratory tests, not subjective expert reviews or adjudication of medical cases.

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 section is not applicable. The device is a patient examination glove, not an AI-powered diagnostic or assistive tool that would involve human readers or MRMC studies.

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

This section is not applicable. The device is a physical product (glove), not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for this device is based on technical standards and objective laboratory measurements. This includes:

• ASTM standards (D 5250-06, D6124-06) for physical properties, dimensions, and powder residual.
• 21 CFR 800.20 for freedom from pinholes.
• ISO 10993-10 for biocompatibility (Primary Skin Irritation and Dermal Sensitization).

8. The Sample Size for the Training Set

This section is not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set."

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

This section is not applicable for the reason stated above.

Ask a specific question about this device