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A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.

Thermoplastic Elastomer (TPE) Hybrid Examination Glove is a patient examination glove made from polyethylene resin and styrene-ethylene-styrene (SEBS) compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the Thermoplastic Elastomer (TPE) Hybrid Examination Glove:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the exact sample sizes used for each individual test. It states that "the following bench testing was conducted for design elements and performance characteristics deemed appropriate to demonstrate equivalence to the predicate device."

The provenance of the data is from Xuzhou Full Sun Medical Products Ltd. (China), as indicated by the submitter's address and the company branding throughout the document. The tests are non-clinical bench tests, meaning they were performed in a lab setting rather than on human subjects.

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

This information is not applicable to this type of device and study. The "ground truth" for examination gloves is established by objective engineering and biocompatibility standards (e.g., ASTM, ISO standards) and not by expert consensus in the typical sense of medical image interpretation.

4. Adjudication Method for the Test Set:

This information is not applicable. The tests are objective measurements against defined acceptance criteria from established standards. There is no human interpretation or adjudication involved in the test results beyond the standard practices of laboratory testing and quality control.

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:

This information is not applicable. This device is a physical medical product (examination glove), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.

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

This information is not applicable. As stated above, this is a physical medical product, not an algorithm.

7. The type of ground truth used:

The ground truth used for this device is based on established industry standards and regulatory requirements for medical examination gloves. Specifically:

• Engineering Standards: ASTM D3767, ASTM D5151-19, ASTM D412-16, ASTM D573-04, ASTM D6124-06 for dimensions, freedom from holes, tensile strength, elongation, and powder residue.
• Biocompatibility Standards: ISO 10993-10:2010 (Skin Irritation and Sensitization) and ISO 10993-5:2009 (Cytotoxicity).
• Regulatory Standards: 21 CFR 800.20 (Freedom from holes).

These standards define the acceptable physical, mechanical, and biological properties a glove must possess to be deemed safe and effective for its intended use.

8. The Sample Size for the Training Set:

This information is not applicable. This is a physical product, not a machine learning model, so there is no concept of a "training set" in this context.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable. As explained in point 8, there is no training set for a physical examination glove.

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