Search Results

The Polychloroprene Powder Free Surgical Glove (Green) is made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Polychloroprene Powder Free Surgical Glove (Green) is made of synthetic rubber.

Based on the provided text, the document is a 510(k) premarket notification decision letter for a medical device: "Polychloroprene Powder Free Surgical Glove (Green)".

Crucially, this document does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of an AI-powered medical device.

The document is a regulatory approval letter from the FDA, confirming that the device is substantially equivalent to legally marketed predicate devices. The "Indications for Use" section simply describes the intended use of the surgical glove (to protect a surgical wound from contamination).

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication method for a test set.
5. MRMC study details or effect size on human readers.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This type of information would typically be found in a more detailed technical report or study submission, not in the FDA's decision letter itself, especially for a Class I device like a surgical glove, which doesn't involve complex algorithms or AI performance testing.

Ask a specific question about this device