Powder Free Nitrile Patient Examination Gloves, White 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.

Powder Free Nitrile Patient Examination Gloves, White Color are made of synthetic rubber, intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The device meets all of the requirements of ASTM standard D 6319 00a (2005)e1.

The acceptance criteria and study proving the device meets these criteria are described below.

1. Acceptance Criteria and Device Performance

The device is "Powder Free Nitrile Patient Examination Gloves, White Color". The acceptance criteria and reported device performance are presented in the table below:

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

The document does not specify the exact sample sizes for the testing of the "Powder Free Nitrile Patient Examination Gloves, White Color." However, it states that the device meets various ASTM standards and CFR regulations, implying specific sample sizes as dictated by those standards.

The data provenance is not explicitly stated in terms of country of origin but is implied to be internal testing conducted by the manufacturer, Jiangsu Dongling Plastic & Rubber Co.,Ltd, located in China. The study appears to be retrospective in nature, as it involves testing the finalized product against established standards.

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

This information is not provided in the document, as the testing involves meeting regulatory and industrial standards (e.g., ASTM, FDA 21 CFR) for product characteristics, rather than diagnostic accuracy requiring expert consensus.

4. Adjudication method for the test set

An adjudication method is not applicable and therefore not described in the document. The testing involves objective measurements against predefined standards for glove characteristics, not subjective interpretations requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

An MRMC comparative effectiveness study was not done and is not applicable to this device. This type of study is typically used for diagnostic devices involving image interpretation or other subjective assessments. The "Powder Free Nitrile Patient Examination Gloves, White Color" is a medical device (patient examination glove) whose effectiveness is determined by its physical and chemical properties as per standards, not by human reader interpretation.

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

A standalone performance study is not applicable to this device. This type of study is typically associated with AI/algorithm-based diagnostic tools. The "Powder Free Nitrile Patient Examination Gloves, White Color" is a physical medical device.

7. Type of ground truth used

The ground truth used for evaluating the "Powder Free Nitrile Patient Examination Gloves, White Color" is based on established industry and regulatory standards:

• ASTM standard D 6319 00a (2005)e1: For dimensions and physical properties.
• 21 CFR 800.20: For freedom from pinholes (waterleak test on pinhole AQL).
• ASTM standard D6124-06: For powder residual.
• ISO 10993-10: 2002/Amd. 1: 2006: For biocompatibility (primary skin irritation and dermal sensitization).

These standards define the acceptable performance parameters.

8. Sample size for the training set

This information is not applicable and therefore not provided in the document. The "Powder Free Nitrile Patient Examination Gloves, White Color" is a physical medical device, not an AI/algorithm-based device that requires a training set.

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

This information is not applicable and therefore not provided in the document. As stated above, this device does not utilize a training set in the context of inferential algorithms.

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