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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.

Ask a specific question about this device