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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. The extra thickness of this glove is suitable for use in an environment of higher risks, such as Paramedics, Emergency Room, etc. This glove may also provide additional protection in other areas where users are handling certain hazardous chemicals such as chemotherapy drugs, as penetration and permeation to these chemicals are prevented.

Absogel Powder Free Latex Examination Gloves with Protein Content (50 micrograms or less) and Chemotherapy Drug Protection Claims

This document is a 510(k) clearance letter from the FDA for a medical device: "Absogel Powder Free Latex Examination Gloves with Tested For Use With Chemotherapy Drugs & Protein Content (50 micrograms or less) Labeling Claims".

The document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way you've described, which typically applies to AI/software as a medical device (SaMD) or diagnostic devices. Instead, this is a clearance for a physical medical glove.

Here's why the requested information cannot be extracted from this document:

• No AI/Software: This document is for latex examination gloves, a physical product, not an AI or software device. Therefore, concepts like "algorithm only performance," "human-in-the-loop performance," "effect size of human readers improving with AI," "training set," "test set," "ground truth," and "expert adjudication" are not applicable.
• Substantial Equivalence: The FDA clearance is based on "substantial equivalence" to a predicate device, meaning the new device is as safe and effective as a legally marketed device. This process generally involves demonstrating that the new device has the same intended use, technological characteristics, and performs similarly to the predicate. It does not typically involve the kind of rigorous performance studies with acceptance criteria and ground truth methodologies you've asked about for AI/SaMD.
• Product Performance Data (for gloves): While gloves do have performance criteria (e.g., barrier integrity, tensile strength, protein content, chemotherapy drug permeation), these are verified through established testing standards (e.g., ASTM standards) rather than the type of clinical or reader studies you've described. The document mentions "Tested For Use With Chemotherapy Drugs & Protein Content (50 micrograms or less) Labeling Claims," which implies such testing was done and submitted as part of the 510(k) application, but the details of those tests (acceptance criteria, methodologies, results) are not in this letter.

Therefore, I cannot provide the requested table and study details as they are not present in the provided FDA clearance letter for this type of medical device.

The document primarily states:

• Device Name: Absogel Powder Free Latex Examination Gloves with Protein Content (50 micrograms or less) and Chemotherapy Drug Protection Claims
• Regulatory Class: I
• Product Code: LYY
• Indicated Use: Disposable device intended for medical purposes, worn on hand/finger to prevent contamination. Extra thickness for higher risks (Paramedics, ER). Additional protection when handling certain hazardous chemicals like chemotherapy drugs (penetration/permeation prevented).

To get the type of information you are asking for, you would need to look at the actual 510(k) submission on file (K990677) where the manufacturer would have submitted their test data for things like chemotherapy drug permeation and protein content, demonstrating compliance with relevant standards. However, even those wouldn't align with the "AI/SaMD" specific questions you've posed.

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