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The device is a disposable examination glove made of synthetic rubber intended for medical purposes and is donned by the user on the hands to prevent possible contamination between patient and examiner.

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This document is an FDA 510(k) clearance letter for a medical device: "Neosoothe Polychloroprene, Powder-Free Examination Gloves With Aloe". This type of document is a regulatory approval and does not contain the kind of information requested in the prompt (acceptance criteria, study details, sample sizes, expert qualifications, etc.).

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This means the device was found to be similar enough to an already approved device, rather than undergoing a new, de novo clinical study with specific acceptance criteria and detailed performance reporting as if it were a novel AI/software product.

Therefore, I cannot extract the requested information from the provided text. The prompt's questions are geared towards the evaluation of algorithms or diagnostics with measurable performance metrics, which is not applicable to an examination glove's 510(k) clearance process.

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