(55 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, Beige color (Sensi-Pro)
This document is a 510(k) premarket notification letter from the FDA regarding "Disposable Powdered Vinyl Synthetic Examination Gloves, Beige color (Brand Name: Sensi-Pro)". It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The letter is an approval for the device based on its substantial equivalence to a predicate device already on the market, not a report of a new study designed to prove specific performance metrics.
Therefore, I cannot extract the requested information from the provided text. The document confirms the FDA's decision regarding the device's market eligibility but does not detail the technical studies, acceptance criteria, or performance data that would generally be part of a submission proving the device's technical capabilities.
§ 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.