(71 days)
A patient examination Latex Powdered Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Latex Powdered Examination Glove
The provided text is a 510(k) premarket notification letter from the FDA to High Momentum SDN. BHD. regarding a Latex Powdered Examination Glove. It primarily addresses the substantial equivalence determination for the device, and does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on equivalence to a predicate device, not on detailed performance study results against specific criteria.
§ 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.