(277 days)
The Biodegradable Nitrile Powder Free Examination Glove (Blue) is a non-sterile disposable device intended for medical purpose that is worn on examinet's hand to prevent contamination between patient and examiner.
Biodegradable Nitrile Powder Free Examination Glove (Blue)
This document is a 510(k) premarket notification letter from the FDA regarding a Biodegradable Nitrile Powder Free Examination Glove (Blue). It does not contain information about the acceptance criteria or a study proving the device meets those criteria.
The letter acknowledges that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It primarily deals with the regulatory classification, general controls, and other administrative information for getting the device approved for marketing.
Therefore, based on the provided text, I cannot extract the requested information about acceptance criteria and a study proving the device meets those criteria.
This type of information is typically found in the 510(k) summary or detailed test reports, which are not part of this specific letter.
§ 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.