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A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.

The Powder-Free Blue Nitrile Examination Gloves Peppermint Scented meets all requirements of ASTM D 6319-10 and FDA 21 CFR 800.20. The device is made out of nitrile.

The provided 510(k) summary (K121528) describes the acceptance criteria and performance of Powder-Free Blue Nitrile Examination Gloves, Peppermint Scented. The study is a non-clinical performance assessment comparing the new device against established standards and a predicate device (K090194).

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 sample sizes used for each specific test (e.g., number of gloves tested for pinholes, physical properties, etc.). It only mentions that the device "Meets" the standards, implying that adequate samples were tested to demonstrate compliance.

The data provenance is retrospective and non-clinical. The testing was conducted on samples of the new device and compared against established ASTM standards and the characteristics of a predicate device. The origin of the data (country where tests were performed) is not specified, but the manufacturer is based in China.

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

Not applicable. This device is a medical glove, and the acceptance criteria are based on objective, standardized physical and chemical tests (ASTM standards, FDA regulations), not on subjective expert interpretation of medical images or patient data. Therefore, "ground truth" as established by medical experts is not relevant in this context.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the assessment relies on objective measurements against predefined standards, not on human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is not relevant for this type of device. This is a non-clinical performance evaluation of a glove, not an imaging diagnostic device or a device requiring human reader interpretation.

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

Not applicable. This device is not an algorithm or an AI-powered system. It is a physical medical device (examination glove). The performance described is its inherent physical and biological characteristics.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is defined by established consensus standards and regulatory requirements. Specifically:

• ASTM International Standards: ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application), ASTM D6124-06 (Standard Test Method for Residual Powder on Medical Gloves), ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves), and ASTM D412 (Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension).
• FDA Regulations: Specifically, 21 CFR 800.20 ("Patient examination gloves").
• Biocompatibility Testing Guidelines: Primary Skin Irritation and Dermal Sensitization tests are standard biological evaluation methods for medical devices.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI. Performance is evaluated through physical and chemical testing of manufactured gloves.

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

Not applicable, as there is no training set for this type of device. The ground truth for the performance evaluation is established by the referenced ASTM and FDA standards and recognized biocompatibility testing methods.

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A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.

The Powder-Free Nitrile Examination Gloves, Orange is substantial equivalent to Powder-Free Nitrile Examination Gloves, Black Color with 510k number K090194 that is currently marketed. The device modification is a change in color from Black to Orange. Another device modification is the addition of adding a citric acid coating to the interior surface of the gloves to achieve a pH of 5.0 - 5.5 for the inner surface of the glove.

The provided document is a 510(k) Summary for Powder-Free Nitrile Examination Gloves, Orange Color. It describes the device, its intended use, and a summary of technological characteristics compared to standards. The document does not describe a study in the context of an AI/ML medical device with the information requested (e.g., sample sizes for test/training, number of experts, adjudication methods, MRMC studies, or specific ground truth types like pathology or outcomes data).

Instead, this document is a submission to the FDA demonstrating substantial equivalence for a medical device (gloves) by confirming its compliance with established performance standards.

Therefore, many of the requested fields cannot be filled from the provided text as they are not applicable to this type of device submission.

Here's an attempt to answer based on the provided document, using "N/A" where information is not present or not relevant to the type of device:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size: Not explicitly stated. The tests are described as conforming to ASTM standards and FDA regulations, which imply specific sample sizes for various tests (e.g., AQL 2.5 for pinholes), but these specific numbers are not detailed in the summary.
• Data Provenance: Not specified, but generally, such tests are performed by the manufacturer or a contracted lab to confirm compliance with regulatory standards.
• Retrospective/Prospective: Not applicable in the context of this device type. These are physical/chemical performance tests.

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

• Number of experts: N/A. The "ground truth" for these tests are the established ASTM standards and FDA regulations.
• Qualifications of those experts: N/A.

4. Adjudication method for the test set

• N/A. Compliance is determined by meeting pre-defined physical and chemical specifications, not by expert adjudication.

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

• N/A. This is not an AI/ML device, and no MRMC study was conducted.

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

• N/A. This is not an AI/ML device.

7. The type of ground truth used

• The "ground truth" for the device's performance is compliance with established physical, chemical, and biological standards (ASTM D6319-10, ASTM D 6124-06, FDA 21 CFR 800.20, and biocompatibility tests like Primary Skin Irritation and Dermal Sensitization). It is based on pre-defined engineering and regulatory specifications.

8. The sample size for the training set

• N/A. No "training set" in the context of an AI/ML algorithm is applicable to this device.

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

• N/A. No "training set" is applicable.

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