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Nitrile Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

The subject device in this 510(k) Notification is Nitrile Examination Gloves. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I) for single use only. The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.

The document describes the acceptance criteria and study results for "Nitrile Examination Gloves" (K212551). The device is a non-sterile, powder-free, single-use patient examination glove made from nitrile compound.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

2. Sample sizes for the test set and data provenance:

• The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for physical dimensions, tensile strength, or freedom from holes). Instead, it refers to industry standards (ASTM and ISO). These standards typically specify sampling plans.
• The data provenance is not explicitly mentioned (e.g., country of origin for the testing). The submission is made by "Anhui Fine Glove Medical Technology Co., Ltd" which implies the manufacturing and potentially some testing occurred in China (CN 233100 listed). The correspondent is from Australia. The tests themselves refer to international standards.
• The studies were non-clinical (laboratory-based performance and biocompatibility testing), not based on patient data (retrospective or prospective).

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

• This is not applicable as the studies were non-clinical performance and biocompatibility tests conducted in a laboratory setting against defined technical standards (ASTM, ISO). There was no "ground truth" established by experts in the context of clinical interpretation or diagnosis.

4. Adjudication method for the test set:

• This is not applicable to non-clinical performance and biocompatibility testing against defined technical standards. Test results are objective measurements compared against numerical or qualitative criteria.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

• No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI devices where human readers interpret medical images. The device in question is a medical glove.

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

• This question is not applicable. The device is a physical medical glove and does not involve an AI algorithm. The performance evaluation is based on the physical and chemical properties of the glove itself.

7. The type of ground truth used:

• The "ground truth" for the test set in this context refers to the established technical specifications and criteria defined in the referenced standards: ASTM D6319-19, ASTM D5151-11, ASTM D6124-11, ISO 10993-10, and ISO 10993-5. These standards provide the objective benchmarks for evaluating the glove's performance.

8. The sample size for the training set:

• This is not applicable. The device is a physical product (medical glove) and does not involve an AI model that requires a training set.

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

• This is not applicable, as there is no training set for this type of device.

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