(35 days)
examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner and also to protect the examiner's hands from being affected by the chemicals used in therapy. This glove is to be used in a Non Sterile environment.
BRIGHTWAY TM Brand Powder Free Latex Examination Gloves Blue Color, Non-Sterile ( containing 50 ugm or less of water extractable protein per gram.) (tested for use with Chemotherapy Drugs, Carmustine, Fluorouracil, Methotrexate)
The provided document is a 510(k) premarket notification letter from the FDA for medical examination gloves and does not contain information about acceptance criteria or a study proving a device meets those criteria, particularly for an AI/algorithm-based medical device.
Therefore, I cannot extract any of the requested information from this document. The document primarily focuses on the regulatory approval for a physical medical device (latex examination gloves) and not on a digital device or algorithm with performance metrics.
§ 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.