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The Nitrile Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.

The provided document is a 510(k) summary for a Nitrile Patient Examination Glove, which is a Class I device. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than complex clinical efficacy studies for novel devices.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The sample sizes for specific tests are mentioned:

• Watertightness Test (ASTM D5151): The results indicate samples of 125 or 124 gloves were tested (e.g., 0/125, 1/124).
• Powder Content (ASTM D6124): Tests were conducted for each glove size (XS, S, M, L, XL, XXL). The exact number of samples per size is not specified but is implied to be sufficient for a representative measurement.
• Physical Properties (ASTM D412): Tests were conducted for each glove size (XS, S, M, L, XL, XXL) both before and after aging. The exact number of samples per size for these mechanical tests is not specified.
• Biocompatibility (ISO 10993-5, ISO 10993-10): The sample sizes for these in vitro and in vivo (animals, not human) biocompatibility tests are not explicitly stated in this summary.

Data Provenance: The document does not specify the country of origin of the data providers for the non-clinical tests. Since the submitter is based in China, it's highly probable the testing was conducted in China or by accredited labs recognized by the Chinese regulatory system. All tests are non-clinical (laboratory-based) and are retrospective in nature, as they assess characteristics of manufactured products.

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

This information is not applicable to this device and submission type. The devices are patient examination gloves, and the tests conducted are adherence to international standards for physical properties and biocompatibility. Ground truth in this context is defined by the objective results of these standardized tests, not by expert consensus or interpretations. There are no human "readers" or diagnostic outcomes being evaluated.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human readers interpret data (e.g., medical images) and their decisions need to be resolved or validated, often against a ground truth. The tests for these gloves are objective measurements following established laboratory procedures.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. These studies are typically for diagnostic imaging devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. This submission is for a medical glove, which does not involve human interpretation of cases or AI assistance in a diagnostic capacity.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The device is a physical product (a glove), not an algorithm or AI system. Therefore, standalone algorithm performance is irrelevant.

7. The Type of Ground Truth Used

The "ground truth" for the performance of the Nitrile Patient Examination Glove is established by objective measurements and adherence to recognized international and national standards. Specifically:

• ASTM D6319-19: Standard Specification for Nitrile Examination Gloves for Medical Application.
• ASTM D5151-19: Standard Test Method for Detection of Holes in Medical Gloves.
• ASTM D6124-06 (Reapproved 2017): Standard Test Method for Residual Powder on Medical Gloves.
• ISO 10993-5:2009: Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity.
• ISO 10993-10:2010: Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
• ASTM D412: Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension (implied as referenced for Tensile Strength and Ultimate Elongation).

The ground truth is essentially the quantitative limits and qualitative definitions set forth by these standards.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of this device. Training sets are relevant for machine learning algorithms, which are not involved here. The manufacturer produces the gloves, and samples are selected from production for testing against the established standards.

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

This is not applicable, as there is no training set. The "ground truth" for evaluating the product's performance is derived from the established and published national and international standards mentioned above.

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