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The Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color is 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.

Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color Non-Sterile, is 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 gloves are coated with Aloe Vera, ambidextrous with beaded cuff, green colored, single use disposable devices that comes in six sizes (XS, S, M, L, XL and XXL) supplied in non-sterile state. The qloves are powder free and are manufactured using online chlorination process to avoid sticky surface and obtain good donning properties.

The gloves are made of Nitrile Butadiene Rubber, designed and manufactured in accordance with ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. Its physical and performance characteristics meet all requirements of ASTM D6319-10.

This document is a 510(k) premarket notification for a medical device (Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color). The information provided focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study of AI performance. Therefore, I cannot provide details on AI acceptance criteria, sample sizes for AI tests, expert qualifications, or MRMC studies.

However, I can extract the acceptance criteria and device performance for the glove itself, as per the submitted documentation.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each test listed (e.g., how many gloves were tested for dimensions, pinholes, or physical properties). It refers to meeting the "Standard Requirements" of ASTM D6319-10 and ISO 10993-10. These standards would dictate the sample sizes and methodologies for testing.

The medical device manufacturers are listed as:

• ZHANGJIAGANG DAYU RUBBER PRODUCTS CO., LTD (ZHANGJIAGANG CITY, CHINA)
• ZHENJIANG SUHUI LATEX PRODUCTS CO.LTD. (ZHENJIANG CITY, CHINA)
• NINGXIA MARVISUN RUBBER & PLASTIC PRODUCTS CO., LTD. (YINCHUAN, NINGXIA, CHINA)

Therefore, the tests were presumably conducted in China. The data would be considered prospective as it relates to the testing of this specific device for regulatory submission.

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

This information is not applicable. The "ground truth" for the performance of these gloves is based on established engineering and biological standards (ASTM D6319-10, ISO 10993-10). The performance is assessed through laboratory testing, not expert consensus in the way an AI model's output might be.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods are typically relevant for subjective assessments or when discrepancies arise between multiple human readers and are common in clinical trials or AI performance evaluations. The tests performed for this medical device are objective laboratory measurements against defined standards.

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

No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This type of study is used for evaluating the effectiveness of diagnostic devices, often involving human readers interpreting medical images or data, and comparing their performance with and without an AI assist. This document concerns the physical and biocompatibility testing of medical gloves.

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

This is not applicable. There is no AI algorithm being evaluated in this document.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the device's performance is established by objective measurements and quantitative results from laboratory tests against pre-defined, standardized acceptance criteria specified in documents like ASTM D6319-10 (for physical properties and dimensions) and ISO 10993-10 (for biocompatibility). For example, for "Freedom from pinholes," the ground truth is simply whether the glove passes the specified water leak test.

8. The sample size for the training set

This is not applicable. There is no AI model or training set involved in the evaluation of these medical gloves.

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

This is not applicable as there is no training set mentioned in the document.

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