(73 days)
A Patient Examination Glove is a disposable device intended for medical purposes that is to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Nitrile Patient Examination Gloves (Powder Free)
The provided text is a 510(k) clearance letter from the FDA for "Multi-Comfort Nitrile Examination Gloves, (Powder Free)". This document declares substantial equivalence to a predicate device and permits marketing. It does not contain any information regarding clinical studies, acceptance criteria, or performance data for the device itself.
Therefore, I cannot provide the requested information. The letter only confirms regulatory approval based on substantial equivalence, not on specific performance data from studies described within this document.
§ 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.