(235 days)
BIOTECH Nitrile Examination Gloves are disposable devices intended for medical purpose that are worn on the examiner's hands to prevent contamination between patient and examiner.
BIOTECH Nitrile Examination Gloves
I am sorry, but the provided text only contains an FDA 510(k) clearance letter for "BIOTECH Nitrile Examination Gloves." This document confirms the substantial equivalence of the gloves to previously marketed devices and outlines regulatory requirements.
It does NOT contain any information about acceptance criteria, device performance testing, study design (sample size, data provenance), expert involvement, ground truth establishment, or any details related to an AI-powered medical device.
Therefore, I cannot extract the information required to answer your request. The product in question is a physical medical device (examination gloves), not an AI-based system.
§ 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.