(90 days)
A powder-free 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.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05, Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 23.4 minute and Thiotepa (10.0 mg/ml) has a minimum breakthrough time of 77.5 minute. Warning statements has been included.
WARNING: DO NOT USE WITH CARMUSTINE WARNING: DO NOT USE WITH THIOTEPA
Powder-Free Nitrile Examination Gloves, Blue, Tested for Use With Chemotherapy Drugs
The provided text is a 510(k) premarket notification letter from the FDA regarding "Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs." This document outlines the FDA's substantial equivalence determination for this medical device.
It does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of an AI-powered diagnostic or similar system.
Instead, the document details the "Indications for Use" for the gloves, which includes their general purpose as examination gloves and their tested performance against specific chemotherapy drugs according to ASTM D6978-05.
Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types, or training set details) from the provided text, as these are not relevant to this type of medical device submission.
The table in the document you provided describes the "Minimum Breakthrough Detection Time (Minutes)" for different chemotherapy drugs when tested with the gloves. This is a performance specification for the gloves regarding chemical permeation, not acceptance criteria for an AI product.
§ 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.