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A powdered patient examintaion glove is a disposable device made of natural nubber latex of in for Indications for USE. A powdered patient camming and is intended to be worn on the hand or fingers (s) for synthell material that bears powder to facilities don't is neemals and other conteminants.

A powdered patient examintaion glove is a disposable device made of natural nubber latex of in for Indications for USE. A powdered patient camming and is intended to be worn on the hand or fingers (s) for synthell material that bears powder to facilities don't is neemals and other conteminants.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment relevant to an AI/ML medical device. The document is a 510(k) premarket notification letter from the FDA for "Shanghai Glovmax Enterprise Powdered Blue Nitrile Examination Glove," which is a personal protective equipment (PPE) device.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, and expert details for a test set.
3. Adjudication method for a test set.
4. MRMC comparative effectiveness study details.
5. Standalone algorithm performance.
6. Type of ground truth used.
7. Sample size for the training set.
8. How ground truth for the training set was established.

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