(107 days)
The Nitrile Powder Free Examination Glove - Cobalt Blue (CBLU) is a non - sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner
The Nitrile Powder Free Examination Glove - Dark Violet Blue (DVBU) is a non - sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner
The Nitrile Powder Free Examination Glove - Dawn Blue is a non - sterile disposable device intended for medical purpost that is worn on the examiner's hand to prevent contamination between patient and examiner
The Nittile Powder Free Examination Glove - White is a non - sterile disposable device intended for medical puppose that is wom on the examiner's hand to prevent contamination between patient and examiner
Not Found
This document is a 510(k) premarket notification decision letter from the FDA for several types of Nitrile Powder Free Examination Gloves. It primarily addresses the substantial equivalence of these gloves to legally marketed predicate devices.
Key takeaway: This document is an administrative approval of a medical device (gloves) and does not contain information about acceptance criteria or performance studies as typically described for software or AI/ML devices. The information requested in the prompt, such as sample sizes for test/training sets, ground truth establishment, expert qualifications, and AI-specific study details (MRMC, standalone performance, effect size), is not applicable to this type of regulatory submission for examination gloves.
The approval is based on the device being "substantially equivalent" to predicate devices, meaning it has the same intended use and technological characteristics, or if it has different technological characteristics, it does not raise different questions of safety and effectiveness.
Therefore, I cannot extract the requested information from this document because it is not present. The document focuses on regulatory compliance for a Class I medical device (patient examination glove), not on the performance analysis of a new or AI-powered technology.
§ 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.