(177 days)
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Nitrile Examination Gloves (Powdered) Blue Pur white colors
This document is a 510(k) premarket notification letter from the FDA regarding "Multiple Nitrile Examination Gloves, Powdered with Purple Blue, White Colors." It is not a study report that includes acceptance criteria and performance data for a device.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details. This information is typically found in study reports, clinical trial summaries, or detailed technical documentation, not a 510(k) clearance letter.
§ 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.