(60 days)
A 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 examiners.
Powder-Free Nitrile Examination Glove
The provided text is a 510(k) clearance letter from the FDA for "Health-Plus, Sanitex, Reliance Powder-Free Trade Name: Nitrile Examination Gloves." This document does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria. The letter is a regulatory approval, stating that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information from the given input. The document is about regulatory approval, not performance study details.
§ 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.