(150 days)
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.
Not Found
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.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.