(105 days)
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder Free Nitrile Examination Gloves, Black
The provided document is a 510(k) premarket notification letter from the FDA for "Powder Free Nitrile Examination Gloves, Black." This document does not contain information about acceptance criteria or a study proving a device meets those criteria, as it pertains to AI/medical imaging devices.
Instead, this document is a regulatory letter, indicating that the device has been deemed "substantially equivalent" to legally marketed predicate devices. It outlines the regulatory classification, product code, and relevant FDA regulations for the device (patient examination gloves).
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as none of this information is present in the provided 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.