(59 days)
Nitrile Powder-free Examination Glove is a disposable device made of synthetic materials intended for medical purposes that is worn on the examiner's hand or finger(s) to prevent contamination between patient and examiner.
Nitrile Powder-free Examination Glove is a disposable device made of synthetic materials intended for medical purposes that is worn on the examiner's hand or finger(s) to prevent contamination between patient and examiner.
This document is a 510(k) premarket notification letter from the FDA regarding Motex Nitrile Examination Gloves Powder-Free. It does not contain information about acceptance criteria or a study proving device performance as typically expected for advanced medical devices or AI algorithms. Instead, it is a regulatory document affirming substantial equivalence to a predicate device.
Therefore, I cannot fulfill the request for information on acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies, as this information is not present in the provided text.
The document only states the "Indications For Use" for the gloves: "Nitrile Powder-free Examination Glove is a disposable device made of synthetic materials intended for medical purposes that is worn on the examiner's hand or finger(s) to prevent contamination between patient and examiner."
§ 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.