(133 days)
The Medline Powder-Free Nitrile Examination Glove with Aloe is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Medline Powder-Free Nitrile Examination Glove with Aloe (Green)
The provided document is an FDA 510(k) clearance letter for the "Medline Powder-Free Nitrile Examination Glove with Aloe (Green)". This document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
FDA 510(k) clearance is based on demonstrating substantial equivalence to a legally marketed predicate device, not typically on extensive performance studies that would include the detailed information requested in your prompt. For devices like examination gloves, performance is usually assessed against recognized standards (e.g., ASTM standards for barrier integrity) and compared to the predicate device's performance against those same standards.
Therefore, I cannot extract the information requested from the provided text. The document primarily focuses on the regulatory clearance process and states the device's intended use.
§ 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.