(212 days)
THIS DEVICE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PROPOSE THAI IS WORN ON THE EXAMINER'S HAND TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl
Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl
The provided document is a 510(k) clearance letter from the FDA for medical gloves, specifically "Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl" and "Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl".
This document does not contain any information about an AI/ML medical device, its acceptance criteria, or the study that proves it meets those criteria. It is entirely focused on the regulatory clearance of examination gloves, outlining their indications for use, the chemotherapy drugs they were tested against, and fentanyl permeation times. There is no mention of algorithms, machine learning, human readers, or any other aspects related to AI/ML device evaluation.
Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI/ML device based on 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.