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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, textured fingertip, ambidextrous patient examination glove that meets all of the requirements of ASTM D 6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application

The provided text describes the acceptance criteria and the study conducted for the Kimberly-Clark* STERLING* Nitrile & STERLING* Nitrile-Xtra* Powder-Free Exam Gloves with a Chemotherapy Drug Use Claim. This information is from a Traditional 510(k) summary filed with the FDA.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes for each of the specific non-clinical tests (e.g., number of gloves tested for pinholes, dimensions, or physical properties). For the chemotherapy drug permeation tests, it lists "Average Breakthrough Detection Time," implying multiple tests were conducted for each drug, but the exact number of samples for each is not specified.

The data provenance is not mentioned (e.g., country of origin). The testing would be considered prospective in the sense that the tests were conducted specifically to demonstrate compliance for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This product is a medical glove, not an AI/imaging device requiring expert consensus for ground truth. The "ground truth" for the device's performance is established by the standardized test methods themselves and the quantitative results obtained from those tests. Therefore, experts in establishing "ground truth" in the context of diagnostic interpretation are not applicable here. The experts involved would be those qualified to execute the specific ASTM and ISO standards for glove testing and biocompatibility.

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

Not applicable. Adjudication methods are typically relevant for studies involving human interpretation (e.g., in diagnostic imaging or clinical trials) where disagreements in judgment need to be resolved to establish ground truth. For this type of product and testing, the results are objectively measured per the specified 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 is not an AI-assisted diagnostic or interpretation device that would involve human readers.

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

Not applicable. This is a medical glove, not an algorithm. The "standalone performance" is essentially the results of the physical and chemical tests conducted on the glove itself.

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

The "ground truth" for the performance of these gloves is based on:

• Standardized Test Methods: Adherence to established and recognized industry standards like ASTM D 6319-00a, ASTM D 5151-06, ASTM D 6124-06, ASTM F 739-07, ASTM D 6978-05.
• Biocompatibility Standards: Compliance with ISO 10993 (Parts 10 and 11) for skin irritation, sensitization, and systemic toxicity.
• Quantitative Measurements: Direct measurements of physical properties (dimensions, tensile strength, elasticity), freedom from defects (pinholes), powder content, and breakthrough times for specific chemotherapy drugs.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. As this device does not use a training set, the establishment of ground truth for such a set is irrelevant.

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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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Based upon 21CFR§880.6250 "Patient examination glove": 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.

The powder-free nitrile exam gloves are disposable devices intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient. The powder-free nitrile exam gloves possess the following technological characteristics (as compared to ASTM or equivalent standards): Dimensions Meets ASTM D 6319, Physical Properties Meets ASTM D 6319, Freedom from pinholes Meets ASTM D 6319 Meets ASTM D 5151, Powder Free Meets ASTM D 6124 Meets ASTM D 6319.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the Kimberly-Clark* Sterling* Nitrile Powder-Free Examination Glove:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The document does not explicitly state the sample sizes used for each specific test (e.g., for dimensions, physical properties, or biocompatibility). However, it implies that the tests were conducted according to established ASTM and ISO standards, which would typically specify sample sizes.

The data provenance is not specified. It's likely that the testing was performed by Kimberly-Clark or a contract lab on product manufactured by Kimberly-Clark.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The ground truth for this device (examination gloves) is based on objective, standardized physical and biocompatibility tests, not expert interpretation of medical images or conditions.

4. Adjudication Method for Test Set

Not applicable. This type of device relies on objective, measurable test results against pre-defined standards, not subjective adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a medical device (examination glove) subject to physical and biocompatibility testing, not an AI or diagnostic imaging system that would involve human readers.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a physical medical device, not an algorithm. The performance evaluation is based on the device's inherent characteristics against established standards.

7. Type of Ground Truth Used

The ground truth used for this device is based on objective standards and test results. Specifically:

• ASTM Standards: Defined specifications for physical properties, dimensions, and freedom from pinholes.
• ISO Standards: Defined methods and acceptable limits for biocompatibility testing (irritation, sensitization, systemic toxicity).
• USP (United States Pharmacopeia): Also referenced for the systemic toxicity study extract.

8. Sample Size for the Training Set

Not applicable. Examination gloves do not typically involve a "training set" in the context of machine learning or AI. Performance is evaluated on product that is representative of production.

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

Not applicable, as there is no "training set." The performance of the device is assessed against established, regulatory-accepted standards (ASTM, ISO, USP) for examination gloves.

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