(54 days)
A Medical disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
Disposable Powder Free Vinyl Synthetic Examination Gloves, Beige color (Sensi-Pro)
The provided text is a 510(k) premarket notification approval letter for "Disposable Powder Free Vinyl Synthetic Examination Gloves, Beige Color (Brand Name: Sensi-Pro)". This document is a regulatory approval and does not contain information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other technical details requested in the prompt.
Therefore, I cannot provide the requested information based on the given input 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.