(105 days)
A Nitrile powder free 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. (21 CFR 880.6250)
Model 1: White Nitrile, Powder Free Examination Gloves
Model 2: Blue Nitrile, Powder Free Examination Gloves
Model 3: Pink Nitrile, Powder Free Examination Gloves
The input document is a letter from the FDA regarding a 510(k) premarket notification for "Elegant Powder Free Nitrile Examination Gloves". It primarily addresses the substantial equivalence determination for the device. The document does not contain any information about acceptance criteria for a device's performance, nor does it describe any study related to device performance, sample sizes, ground truth establishment, or expert adjudication that would be relevant to the questions posed.
Therefore, I cannot provide the requested information based on the provided text. The questions are designed for a document describing a clinical study or performance evaluation of a medical device, which this document is not.
§ 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.