(75 days)
A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder-Free Nitrile Examination Gloves (Polymer Coated)
This document is a 510(k) clearance letter from the FDA for "Powder-Free Nitrile Examination Gloves (Polymer Coated)". It does not contain information about acceptance criteria or a study proving that a device meets those criteria. The letter primarily states that the device is substantially equivalent to a legally marketed predicate device.
Therefore, I cannot provide the requested information based on 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.