(85 days)
The 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.
Nitrile Exam Glove, Powder-Free Model Color White, Blue
This document is a 510(k) clearance letter from the FDA for a Nitrile Exam Glove. It does not contain information about the acceptance criteria or a study that proves a device meets such criteria, as it is for a low-risk device (Class I) that typically does not require extensive clinical studies or performance acceptance criteria beyond established standards for gloves (e.g., integrity, barrier protection).
Therefore, I cannot extract the requested information from 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.