(37 days)
A patient examination Nitrile Blue Powdered Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Nitrile Blue Powdered Examination Glove
The provided document is a 510(k) premarket notification letter from the FDA for a Nitrile Blue Powdered Examination Glove. It is a regulatory document affirming equivalence to a predicate device and does not contain information about acceptance criteria or performance studies as typically described for a medical device that relies on algorithmic or diagnostic performance.
Therefore, I cannot answer your request regarding acceptance criteria and device performance studies because the information is not present in the provided text. The document is about a physical medical device (examination glove) that falls under general controls and does not involve AI or complex performance metrics as implied by your questions.
§ 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.