(54 days)
This Nitrile 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, and has also been Tested for Use with the Opioid Fentanyl citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid.
Black Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid
This document is a 510(k) premarket notification decision letter from the FDA for a medical device: "Black Nitrile Powder Free Patient Examination Glove". It does not describe an AI/ML powered device, therefore, the requested information regarding acceptance criteria and study details for an AI-based device is not applicable and cannot be extracted from this document.
The document focuses on:
- The FDA's determination of substantial equivalence for the glove to legally marketed predicate devices.
- The regulatory classification and applicable regulations for the device.
- A table of test results for the glove's resistance to various chemotherapy drugs, fentanyl citrate, and simulated gastric acid, along with breakthrough times. This is performance data for the physical glove, not an AI model.
§ 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.