(68 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.
Syntex Pre-Powdered Latex Examination Glove
The provided text is a FDA 510(k) clearance letter for a medical device: "Syntex Pre-Powdered Latex Examination Glove."
This type of document does not contain the detailed technical information requested about acceptance criteria and study designs that prove device performance.
FDA 510(k) clearances are based on demonstrating substantial equivalence to a predicate device, not necessarily on new, extensive clinical studies proving efficacy or specific performance metrics in the way a PMA (Premarket Approval) would.
Therefore, I cannot provide the requested information from the given input. The letter essentially states that the device is "substantially equivalent" for its indicated use based on the information provided in the 510(k) submission, and it lists various regulatory requirements for the manufacturer.
§ 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.