(114 days)
A powder-free examination glove is a disposable device intended for medical purposes, that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves are available with finger textured surface. Sizes; Extra Small and XX-Large.
Midas Touch-Nitrile Examination Gloves - Powder free, Orange, XS, Model SNAEFT-240OR-XS Midas Touch-Nitrile Examination Gloves - Powder free, Orange, XXL, Model SNAEFT-240OR-XXL
This is a 510(k) premarket notification for "Midas Touch-Nitrile Examination Gloves". This document does not describe a study involving device performance metrics, algorithms, human readers, or ground truth as would be found in a submission for an AI/ML-based medical device. Instead, it is an administrative letter from the FDA confirming substantial equivalence for a physical medical device (examination gloves) to predicate devices.
Therefore, I cannot provide the information requested in your prompt as it is not present in the provided text. The prompt's questions pertain to acceptance criteria and studies for AI/ML device performance, which are not relevant to this 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.