(63 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder-Free Polymer-Coated Latex Examination Glove
This document is a 510(k) premarket notification letter for a Syntex Powder-Free Polymer-Coated Latex Examination Glove. It is from the FDA to Syntex Healthcare Products Co Ltd. and states that the device is substantially equivalent to legally marketed predicate devices.
This document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory approval letter based on substantial equivalence, not a performance study report.
Therefore, I cannot provide the requested table or answer any of the questions about a performance study, sample sizes, ground truth, or expert qualifications based on the provided text.
§ 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.