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The Kimberly-Clark* STERLING Nitrile Powder-Free Exam Glove, Sterile, is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Based upon 21CFR§880.6250 "Patient examination glove" Use: A patient examination glove is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Light gray nitrile, chlorinated, powder-free, sterile, textured fingertip, ambidextrous patient examination glove

The Kimberly-Clark* Sterile STERLING* Nitrile Powder-Free Exam Glove (K081027) is a patient examination glove. The following information details its acceptance criteria and the study that proves the device meets these criteria:

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

The acceptance criteria for this device are based on compliance with several ASTM and ISO standards for properties typical of patient examination gloves. The device's performance is reported as meeting these requirements based on non-clinical tests.

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

The document does not specify the exact sample sizes for each non-clinical test. The data provenance is derived from internal non-clinical laboratory and animal-based biocompatibility tests conducted by Kimberly-Clark Corporation to confirm compliance with established standards. The data is retrospective in the sense that it pertains to the product being submitted for 510(k) clearance, reflecting the outcome of these tests.

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

Not applicable. The ground truth for this device is established through compliance with recognized industry standards (ASTM and ISO) for physical properties, sterility, and biocompatibility. These standards define the objective measures for performance, rather than requiring expert consensus for a "ground truth" in the diagnostic sense.

4. Adjudication method for the test set

Not applicable. As the evaluation relies on objective measurements against established standards, an adjudication method in the context of expert review is not required. The results of the non-clinical tests are directly compared to the specified limits of the standards.

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 device is a sterile patient examination glove and does not involve AI assistance or human-reader interpretations.

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

Not applicable. This device is a physical medical device and does not involve an algorithm.

7. The type of ground truth used

The ground truth is established through objective measurements compared against published national and international standards (ASTM, ISO) for physical properties, sterility, and biocompatibility. For example, for "Freedom from pinholes," the ground truth is defined by the AQL (Acceptable Quality Level) of 2.5 specified in ASTM D 5151-06.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so there is no "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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