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The powder free patient examination gloves are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner. The device is for over the counter use.

Medcare Powder-Free Blue Nitrile Patient Examination Gloves are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are nitrile, powder- free, ambidextrous, and blue-colored with a beaded cuff. The proposed device is offered in the following sizes: S, M, L, XL.

Here's a breakdown of the acceptance criteria and study information for the Medcare Powder-Free Blue Nitrile Patient Examination Gloves (K211808) based on the provided text, formatted to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Since the device is a Class I medical device (patient examination gloves), the studies described are non-clinical performance tests to demonstrate substantial equivalence to a predicate device, not typical clinical studies with human participants that would involve the following points you requested. Therefore, for most of the remaining points, the answer is "Not Applicable" or "Not Provided" in the context of this 510(k) submission.

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

• Sample size: Not explicitly stated for each individual test, but the ASTM and ISO standards for material testing typically specify sample sizes.
• Data provenance: Not explicitly stated whether retrospective or prospective. The manufacturer is Dongguan Grinvald Technology Co., Ltd. - China.

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

• Not Applicable. These are objective, quantitative material and biological tests performed according to standardized protocols (ASTM, ISO). "Ground truth" in the clinical sense with expert consensus is not relevant here. The "experts" would be the accredited laboratory personnel performing the tests according to the standard methods.

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

• None. Adjudication methods are typically used for subjective assessments or when there's disagreement among human readers in interpreting clinical data. These non-clinical tests have objective pass/fail criteria.

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 a non-clinical device (patient examination glove). AI assistance or human reader improvement studies are not relevant to its regulatory pathway.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• Objective, standardized test results. The "ground truth" is established by the specified acceptance criteria within each ASTM or ISO standard, which are quantitative thresholds for physical properties and defined biological responses.

8. The sample size for the training set

• Not Applicable. This device does not involve a training set in the machine learning context. The "training" for the device's manufacturing would be adherence to quality control procedures and standard operating procedures.

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

• Not Applicable. As above, no training set for an algorithm is involved.

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