(105 days)
Senstouch High Risk Blue Latex Examination Gloves Powdeced, Non-Starile is a disposable device and mad of natural cubber latex for medical purpose that worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Senstouch High Risk Blue Latex Examination Gloves, Powdered, Non-Sterile is a disposable device and made of natural rubber latex.
The provided text discusses an FDA 510(k) premarket notification for "Senstouch High Risk Blue Latex Examination Gloves, Powdered, Non-Sterile." It states that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain any information regarding acceptance criteria, device performance results, sample sizes, ground truth establishment, expert qualifications, or study methodologies. It is a regulatory approval letter, not a performance study report.
Therefore, I cannot provide the requested information based on the given input.
§ 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.