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A medical gloves is worn on the hand 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 from the FDA for medical gloves, and it does not contain the type of information requested in the prompt. The request asks for details about a study and acceptance criteria for a device, which typically refers to a diagnostic or therapeutic device whose performance is measured against specific metrics.

This document, however, is solely about the regulatory clearance of "NITRI GRIP Powdered Nitrile Examination Gloves" and confirms their substantial equivalence to predicate devices, thus allowing them to be marketed. It does not include:

• A table of acceptance criteria and device performance.
• Details about a test set (sample size, data provenance, ground truth experts, adjudication).
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.
• Details on a training set or how ground truth for training was established.

The "Indications for Use" section (page 2) simply states the purpose of the gloves, which is to prevent contamination between healthcare personnel and patients, not a performance metric for which a study with acceptance criteria would be conducted in the context of the prompt's questions.

Therefore, I cannot fulfill the request based on the provided document.

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A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

POWDER FREE NITRILE EXAMINATION GLOVES, Blue

The provided document is an FDA 510(k) clearance letter for "Powder Free Nitrile Examination Gloves, Blue". This type of document generally does not contain the detailed study information or acceptance criteria as requested in the prompt.

FDA 510(k) clearances are based on demonstrating "substantial equivalence" to a predicate device, not necessarily on specific performance studies with detailed acceptance criteria as one would find for a novel diagnostic or AI-powered medical device. The letter confirms that the device meets the general controls provisions of the Act and is classified as Class I.

Therefore, I cannot extract the requested information from this document. The prompt asks for details like:

• A table of acceptance criteria and reported device performance
• Sample size and data provenance for the test set
• Number and qualifications of experts for ground truth
• Adjudication method
• MRMC study details and effect size
• Standalone performance
• Type of ground truth used
• Training set sample size and ground truth establishment

None of these details are typically included in an FDA 510(k) clearance letter for a Class I medical glove. These details would be part of a submission for a more complex device, especially those involving algorithms or advanced functionality.

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A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

POWDERED FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MIGROGRAM OR LESS).

This document is a 510(k) clearance letter for "Ultra Touch Powder-Free Latex Examination Gloves With Protein Labeling Claim (50 Micrograms or Less)". It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information.

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A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Not Found

The provided text is a 510(k) premarket notification for "Ultra Touch Powdered Latex Examination Gloves, with Protein Labeling Claim (120 Micrograms or Less)". This document is a regulatory approval letter from the FDA, and it does not contain information about acceptance criteria or a study proving device performance.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials or performance studies with specific acceptance criteria that would typically be detailed for a novel device.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or MRMC comparative effectiveness studies from the provided text.

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