(204 days)
A 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.
Powder - Free Latex Examination Gloves
This letter does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance. This document is a 510(k) clearance letter from the FDA for "Powder-Free Latex Examination Gloves."
Here's why the information you're looking for is not present in this document:
- 510(k) Clearance: A 510(k) clearance primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, not necessarily on a detailed performance study against specific acceptance criteria for a new, innovative device feature.
- Device Type: Examination gloves are Class I devices, which generally have lower regulatory hurdles and do not typically require extensive clinical trials or complex performance studies like those for AI/ML-driven medical devices. Their primary performance metrics relate to barrier integrity, strength, and biological safety.
- Date: This document is from 1997, predating the modern regulatory framework and robust performance study expectations for AI/ML devices.
To provide the information you requested, I would need a document such as:
- A clinical study report for an AI/ML medical device.
- A performance evaluation section from a regulatory submission for a novel AI/ML device.
- A peer-reviewed publication detailing the validation of an AI/ML algorithm.
Therefore, I cannot populate the table or answer the specific questions based on the provided text.
§ 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.