(246 days)
These Non-Sterile, Powder-Free, AQUA NITRILE Examination Gloves with Lano-E and Peppermint Citrus Scent, are a disposable (single-use-only) device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Non-Sterile, Powder Free, AOUA NITRILE Examination Gloves with Lano- E and Peppermint Citrus Scent
I cannot fulfill this request. The provided text is a Food and Drug Administration (FDA) clearance letter for a medical device (examination gloves), not a study report or clinical trial documentation. Therefore, it does not contain information about acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or any of the other specific details requested in the prompt. This document attests to the substantial equivalence of the device to legally marketed predicate devices, but it does not present the results of a study that would "prove the device meets acceptance criteria" in the way described in the prompt.
§ 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.