(60 days)
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs.
Powder Free Nitrile Examination Glove (Blue). This Product Does Not Contain Thiuram, and/or Carbamate and/or Thiazole. Tested For Use With Chemotherapy Drugs.
This document is a 510(k) premarket notification letter for "Powder Free Nitrile Examination Gloves (Blue)". It describes the device and its intended use, but it does not contain any information about acceptance criteria or a study proving the device meets those criteria from an AI/algorithm perspective.
The device in question is a medical glove, which is a physical product, not an AI or algorithm. Therefore, the questions posed regarding AI performance metrics, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment for training sets are not applicable to the content of this document.
The letter states that the FDA found the device "substantially equivalent" to legally marketed predicate devices, meaning it met the requirements for this type of medical device at the time of review (October 2008), but it doesn't detail performance studies in the way an AI/algorithm development report would.
§ 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.