(37 days)
A Medical disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
Disposable Powdered Vinyl Synthetic Examination Gloves, White color (Sensi-Pro)
The provided text is a 510(k) premarket notification approval letter for "Sensi-Pro, Disposable Powdered Vinyl Synthetic Examination Gloves." This document does not contain information about acceptance criteria or a study that proves the device meets those criteria, as requested in the prompt. The letter merely acknowledges that the device is substantially equivalent to a predicate device and can be marketed.
Therefore, I cannot extract the requested information from 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.