(163 days)
A 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
Powder Free Latex Examination Glove, Polymer Coated
The provided text is a 510(k) clearance letter from the FDA for a Powder Free Latex Examination Glove, Polymer Coated. This document does not contain information about acceptance criteria or a study proving that an AI/ML-enabled device meets those criteria.
The information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is specific to the evaluation of AI/ML performance in a medical device context. This document, however, pertains to a physical medical device (examination gloves) and its substantial equivalence to a predicate device based on its intended use and general controls.
Therefore, I cannot provide the requested information based on the input text.
§ 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.