(44 days)
The nitrile examination gloves is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Nitrile Powder Free Examination Gloves (Green)
This document is a 510(k) clearance letter from the FDA for Nitrile Powder Free Examination Gloves. It does not contain information about the acceptance criteria or a study proving device performance as it pertains to AI/ML or diagnostic devices. The details requested in your prompt (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance experiments) are typically associated with the evaluation of artificial intelligence or machine learning-based medical devices, not with the clearance of basic medical supplies like examination gloves.
Therefore, I cannot provide the requested information based on the given document.
§ 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.