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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Non sterile, Powder free Nitrile Examination Glove, Blue.

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified in the provided text. The document states "The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above," referring to the table of characteristics, but does not detail the sample sizes used for each test.
• Data Provenance: Not explicitly stated as retrospective or prospective, or country of origin for the data collection itself. However, the tests cited are ASTM standards, which are internationally recognized. The manufacturer is Siam Sempermed Corp., Ltd from Thailand.

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

• Not Applicable. This device is a nitrile examination glove. The "ground truth" for its performance is established through standardized physical and biocompatibility testing (e.g., tensile strength, freedom from holes, skin irritation), not through expert interpretation of medical images or clinical outcomes that would require adjudicators.

4. Adjudication method for the test set:

• Not Applicable. As mentioned above, the evaluation of this device relies on standardized physical and chemical tests against ASTM standards, not on subjective assessment or consensus among experts.

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 patient examination glove and does not involve AI or human "readers" in its intended use or evaluation.

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, not an algorithm.

7. The type of ground truth used:

• The "ground truth" is based on objective measurements and observations according to established industry standards (ASTM D 6319-10) for physical properties (dimensions, tensile strength, elongation, freedom from holes, powder residue) and standardized biological assays for biocompatibility (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization).

8. The sample size for the training set:

• Not Applicable. This device concerns a physical product tested against standards, not a machine learning model requiring a training set.

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

• Not Applicable. There is no training set for this type of device.

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