(117 days)
The glove is disposable and intended for Medical purpose that is worn on the hand to prevent contamination between the patient and the examiner.
Polymer Coated Powderfree Latex Examination Gloves
This document is a 510(k) premarket notification letter from the FDA regarding "Polymer Coated Powder Free Latex Examination Gloves." This is a regulatory approval document and does not contain information about acceptance criteria or validation studies in the context of device performance metrics, sample sizes, expert qualifications, or comparative effectiveness studies typically associated with AI/ML-driven device evaluations.
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.