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The disposable medical nitrile examination gloves are intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

The subject device is powder free nitrile examination gloves. The subject device is in blue color. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.

This is a 510(k) summary for Disposable Medical Nitrile Examination Gloves. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not describe a study involving an AI-powered device, human readers, or a ground truth established by experts. Therefore, many of the requested categories are not applicable to the provided text.

Here's a breakdown of the information that can be extracted or noted as not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Sizes:
  • For the Watertightness Test (ASTM D5151): 125 samples are mentioned (0/125/Pass).
  • For other tests (Physical Dimensions, Powder Content, Physical Properties, Biocompatibility), the document does not explicitly state the number of samples tested, but usually, these tests are performed on a representative sample set according to the respective standards.
• Data Provenance: The tests were conducted internally or by accredited laboratories as part of the regulatory submission process for Lanhuo Medical Technology (Jiangsu) Co.,Ltd. The country of origin of the data is China, as the manufacturer and designated correspondent are based there. The data is prospective for this device, meaning the tests were performed on the actual device being submitted.

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

• Not applicable. This document describes non-clinical performance testing of a medical device (nitrile gloves), not an AI algorithm requiring expert-established ground truth. The "ground truth" for these tests is defined by the technical specifications and standards (e.g., a hole is a hole, a measurement passes or fails a defined threshold).

4. Adjudication Method for the Test Set

• Not applicable. This is not a study involving human readers or interpretations needing adjudication. The results are based on objective physical and chemical testing methods.

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 document does not describe a study involving human readers or AI assistance.

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

• Not applicable. This document describes the performance testing of physical examination gloves, not an algorithm.

7. The Type of Ground Truth Used

• Objective Test Standards and Specifications: The "ground truth" for the performance evaluation of the nitrile gloves is established by universally recognized and standardized test methods (e.g., ASTM D6319, ASTM D5151, ASTM D6124, ISO 10993 series). These standards define objective criteria (e.g., specific dimensions, tensile strength, elongation percentages, maximum powder content, absence of holes, and specific biocompatibility responses) that the device must meet.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device. There is no concept of a "training set."

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

• Not applicable. As there is no training set, this question is not relevant.

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