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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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