(82 days)
A 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.
Powdered Nitrile Examination Gloves, Blue
The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for "Powdered Nitrile Examination Gloves, Blue". This document does not contain information about acceptance criteria and a study proving the device meets those criteria, as it pertains to a medical glove. The type of information requested (e.g., sample sizes for training/test sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, ground truth types) is typically found in submissions for AI/ML-based medical devices or diagnostic tools, not for a physical device like examination gloves.
Therefore, I cannot fulfill your request based on 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.