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Nitrile Powder Free 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.

Nitrile films form a barrier to body fluids and bloodborne Pathogens. The nitrile 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. Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Nitrile Powder Free Patient Examination Gloves, Blue Color:

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 size used for each specific test (e.g., number of gloves tested for dimensions, pinholes, etc.). It generally states that the device "meets" the standards, implying that samples were taken and tested according to the specified ASTM or ISO standards.

The data provenance is from China, as the submitter, Wanghui Glove Co., Ltd., is located in Hebei Province, China. The studies are retrospective in the sense that they are reporting results from tests already conducted to demonstrate compliance with established standards.

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

The document does not mention the use of "experts" in the context of establishing ground truth for individual device performance tests. Ground truth for these types of devices is established by conforming to pre-defined, objective, and standardized measurements and test methods outlined in the ASTM and ISO standards themselves. For example, a pinhole test has a clear, objective method for determining the presence or absence of a pinhole (e.g., water leak test).

4. Adjudication Method for the Test Set

No adjudication method is mentioned because the tests are objective and based on established industry standards. There is no subjective human interpretation of results that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human interpretation of medical images or data is involved and the AI's impact on reader performance (e.g., radiologists) is being evaluated. This device is a patient examination glove, and its performance is evaluated against physical and chemical standards, not human diagnostic interpretation.

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

Yes, the device's performance was evaluated in a standalone manner. The tests described (dimensions, physical properties, freedom from pinholes, powder residual, biocompatibility) are all performed directly on the glove material or a batch of gloves. There is no "human-in-the-loop" component to these performance assessments; they are objective measurements against set standards.

7. The Type of Ground Truth Used

The ground truth used for this device is based on established industry standards and objective measurements. Specifically:

• ASTM D6319-10: Standard Specification for Nitrile Examination Gloves for Medical Application
• ASTM D6124-06 (Reapproved 2011): Standard Test Method for Residual Powder on Medical Gloves
• 21 CFR 800.20: General requirements for patient examination gloves (specifically referenced for freedom from pinholes)
• ASTM D5151-06 (Reapproved 2011): Standard Test Method for Detection of Holes in Medical Gloves
• ISO 10993-10: Third Edition 2010-08-01: Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization

These standards define the acceptable ranges or thresholds for various physical and biological properties.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided in the document. This device is a physical product (a glove) evaluated against performance standards, not an AI/ML algorithm that requires a "training set" for model development.

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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