(174 days)
Synthetic Vinyl Examination Glove, Powder Free 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.
Synthetic Vinyl Examination Gloves, Powder-Free
This document is a 510(k) clearance letter from the FDA for "Synthetic Vinyl Examination Gloves, Powder-Free". It does not contain information about acceptance criteria or a study proving that a device meets such criteria.
The letter confirms that the FDA has reviewed the premarket notification for the gloves and determined they are substantially equivalent to predicate devices. It discusses regulatory compliance and general information but does not detail performance criteria or study results.
Therefore, I cannot provide the requested information based on this document.
§ 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.