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An examination glove is a disposable glove intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim, Nitrile Examination Powder Free Glove, Black Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim

This document is a 510(k) premarket notification for nitrile examination gloves and describes their performance against chemotherapy drugs and Fentanyl. It does not describe an AI/ML powered device, therefore, the requested information regarding AI/ML device acceptance criteria and study details cannot be extracted.

The document provides the following information:

• Device: Nitrile Examination Powder Free Glove, Blue and Black
• Intended Use: Disposable medical glove worn on the examiner's hand to prevent contamination between patient and examiner. Tested for use with specific chemotherapy drugs and Fentanyl.
• Testing Standard: ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
• Performance Data: Tables showing the minimum breakthrough detection time in minutes for 32 chemotherapy drugs and Fentanyl for both blue and black gloves. Most drugs show a breakthrough time of >240 minutes, but Carmustine and Thiotepa have significantly shorter breakthrough times.
• Warnings/Cautions: Specific warnings against using Carmustine and cautions regarding the short breakthrough time for Thiotepa.

It does not contain information about:

• Acceptance criteria or studies for an AI/ML powered device.
• Sample sizes for test sets or data provenance in the context of AI/ML.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi Reader Multi Case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Types of ground truth for AI/ML.
• Training set sample sizes or ground truth establishment for AI/ML.

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The glove is disposable and intended for Medical purpose that is worn on the hand to prevent contamination between the patient and the examiner.

Polymer Coated Powderfree Latex Examination Gloves

This document is a 510(k) premarket notification letter from the FDA regarding "Polymer Coated Powder Free Latex Examination Gloves." This is a regulatory approval document and does not contain information about acceptance criteria or validation studies in the context of device performance metrics, sample sizes, expert qualifications, or comparative effectiveness studies typically associated with AI/ML-driven device evaluations.

Therefore, I cannot extract the requested information from the provided text.

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Powdered Latex Examination Gloves are worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient.

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This document is a 510(k) clearance letter for "Top Glove Medical Powdered Latex Examination Gloves." As such, it's a regulatory approval document for a medical device (examination gloves), not a study report for an AI/ML diagnostic device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies cannot be extracted from this document, as these concepts are specific to the evaluation of AI/ML diagnostic tools and are not applicable to the clearance of examination gloves.

The document primarily focuses on:

• Device Identification: Top Glove Medical Powdered Latex Examination Gloves, Regulation Number 880.6250, Product Code LYY.
• Regulatory Status: Substantially equivalent to legally marketed predicate devices, allowing the device to be marketed.
• Intended Use: Worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient.
• Compliance: Compliance with general controls provisions of the Act (registration, listing, GMP, labeling, etc.).

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