(50 days)
A Vinyl examination glove sterile powdered is a disposable device made of polyvinyl chloride paste resin that bears powder to facilitate donning and is intended to be worn on the hands, for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
A Vinyl examination glove sterile powdered is a disposable device made of polyvinyl chloride paste resin that bears powder to facilitate donning and is intended to be worn on the hands, for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
This document is a 510(k) premarket notification letter from the FDA regarding "Vinyl Examination Gloves, Sterile Powdered." It is a regulatory approval, not a study report or clinical trial. Therefore, it does not contain the information requested about acceptance criteria and study details for a device's performance.
To answer your request, a document detailing performance testing, clinical studies, or an substantial equivalence report would be needed. This letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices.
§ 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.