(90 days)
A powder-free patient examination glove (nitrile) is a disposable device made of synthetic material (nitrile latex) that may bear a trace amount of glove powder and is intended to be worn on the hands or finger(s) for medical purposes to provide a barrier against potentially infectious materials and ntoal paiminants. The glove is black with a carbon black colorant additive and polymer coated.
A powder-free patient examination glove (nitrile) is a disposable device made of synthetic material (nitrile latex) that may bear a trace amount of glove powder and is intended to be worn on the hands or finger(s) for medical purposes to provide a barrier against potentially infectious materials and ntoal paiminants. The glove is black with a carbon black colorant additive and polymer coated.
This document is a 510(k) clearance letter for Powder-Free, Black, Nitrile Examination Gloves. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. The letter confirms substantial equivalence to a predicate device, which is based on shared characteristics and performance attributes rather than a specific study outlined here.
Therefore, I cannot provide the requested information.
§ 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.