(85 days)
A Nitrile powder free examination glove is a disposable device intended purposes, worn on the examiner's hand or finger to prevent contamination between examiner and patient. This specialty glove has also been tested for use with 46 Chemotherapy drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate.
Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate (Blue)
This document is an FDA 510(k) premarket notification letter for "Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate (Blue)". This is a Class I medical device (non-powdered patient examination glove).
The document does not describe an AI/ML-driven medical device, nor does it contain information about clinical study results, expert adjudication, or ground truth establishment relevant to AI/ML device performance. It is a regulatory clearance letter for a physical product (gloves) and lists testing results for breakthrough times against various chemicals for the purpose of demonstrating the device's protective capabilities.
Therefore, the requested information cannot be extracted from the provided text. The questions about acceptance criteria, study details, sample sizes, expert involvement, and ground truth are not applicable to the content of this document.
§ 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.