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Powder Free Nitrile Patient Examination Gloves, Blue Color 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.

The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The proposed device is non-sterile.

The provided text is a 510(k) summary for "Powder Free Nitrile Patient Examination Gloves, Blue Color," which is a Class I medical device. This type of device does not typically involve complex algorithms or AI; instead, its performance is evaluated based on physical characteristics and material biocompatibility against established standards. Therefore, the requested information regarding AI-specific evaluation criteria (like multi-reader multi-case studies, expert adjudication, AI effect size, training set details) is not applicable to this submission.

Here's a breakdown of the acceptance criteria and study information that is relevant and available in the document:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes for each physical test. However, it indicates general inspection levels where applicable, such as "ILS-2 AQL4.0" for dimensions and "Inspection Level I AQL2.5" for freedom from pinholes. For residual powder, it states "Checked on 5pcs sub-samples (N=5)."
The provenance of the data is from non-clinical laboratory testing performed by the manufacturer to demonstrate compliance with relevant ASTM and ISO standards. The document does not specify the country of origin of the raw data, but the manufacturer is Shandong Shangwei Medical Products Co.,Ltd, located in China. The studies are prospective in nature, as they are specifically conducted to test the performance of the device against predefined criteria.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The "ground truth" for this device is based on objective measurements against established international and national standards (ASTM, ISO, CFR) for physical properties and biocompatibility. It does not involve expert interpretation or subjective assessment of medical images or patient conditions.

4. Adjudication method for the test set

Not applicable. As described above, this is not an AI or diagnostic device requiring expert adjudication. Test results are quantitative measurements compared against predefined thresholds in 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 device is a patient examination glove and does not involve AI or human "readers" in a diagnostic capacity.

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

Not applicable. There is no algorithm for this device.

7. The type of ground truth used

The ground truth used for this device's evaluation is based on established industry standards and objective laboratory measurements. These include:

• ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application) for dimensions and physical properties.
• 21 CFR 800.20 and ASTM D5151-19 for freedom from pinholes.
• ASTM D6124-06 for residual powder.
• ISO 10993-5, ISO 10993-10, and ISO 10993-11 for biocompatibility (cytotoxicity, irritation, sensitization, systemic toxicity).

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set."

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

Not applicable, as there is no training set for this type of device.

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Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.

Poly Vinyl Chloride (PVC) films form a barrier to prevent contamination between patient and examiner. The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. The Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.

This document is a 510(k) Pre-Market Notification for Powder Free Vinyl Patient Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a novel device meets specific acceptance criteria in a clinical setting.

Therefore, many of the requested sections are not applicable in this context. However, I can extract information related to the device's technical specifications and the non-clinical tests performed to ensure it meets established safety and performance standards for gloves.

Here's a breakdown of the relevant information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally defined by compliance with established ASTM and ISO standards for medical examination gloves. The reported device performance is presented as meeting these standards.

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