(60 days)
A Stretch Vinyl examination glove, Powder Free(Clear(Non-Colored)/Yellow/White) 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.
Powder-Free, Stretch Vinyl Examination Gloves, Clear (Non-Colored) Yellow/White
I apologize, but the provided text from the FDA 510(k) summary is a letter regarding the substantial equivalence determination for "Powder-Free, Stretch Vinyl Examination Gloves, Clear (Non-Colored) Yellow/White."
This document does not contain information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications for a medical device's performance characteristics. It is strictly a regulatory approval letter for examination gloves.
Therefore, I cannot extract the requested information as it is not present in 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.