(45 days)
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
SMART-FEEL Powder Free Nitrile Examination Gloves (Pink Color)
The provided document is a 510(k) premarket notification letter for "Smart-Glove Powder Free Nitrile Examination Gloves Pink Color." This document is a regulatory approval letter from the FDA and does not contain information about acceptance criteria and a study proving device performance as described in the request.
Therefore, I cannot extract the requested information from this document. The document primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements.
§ 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.