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Found 4 results
510(k) Data Aggregation
(71 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
Omni Touch Nitrile Examination Glove, Powdered, Purple
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study proving the device meets them. The document is an FDA 510(k) clearance letter for "Omni Touch Nitrile Examination Glove, Powdered, Purple," which confirms the device's substantial equivalence to predicate devices and permits its marketing.
The letter and the attached "Indications For Use Statement" do not detail:
- Specific acceptance criteria for the device beyond its intended use as a medical glove.
- Any performance study, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies.
Therefore, I cannot fulfill your request with the provided information.
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(62 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
Omni Touch Nitrile Examination Glove, Powdered, White
I am sorry, but because the document is a scanned image, I cannot provide details on the study and acceptance criteria. My current capabilities do not allow me to extract and process information from documents in image format.
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(46 days)
A medical glove is wom on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
Omni Touch Nitrile Examination Glove, Powdered, Blue
This document is a 510(k) clearance letter from the FDA for a medical device: "Omni Touch Nitrile Examination Glove, Powdered, Blue." It signifies that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information regarding specific acceptance criteria, device performance data, study details (sample size, provenance, expert qualifications, adjudication, MRMC studies, standalone performance), or ground truth establishment.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input. The document is a regulatory approval, not a scientific study report.
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(38 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
Not Found
The provided text describes a 510(k) premarket notification for Omni Touch Nitrile Examination Gloves and the FDA's determination of substantial equivalence. It does not contain information about acceptance criteria, device performance metrics, or study details that would typically be found in a clinical trial report or a performance study for an AI/ML device.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information on sample sizes, ground truth establishment, or multi-reader multi-case studies, as none of this information is present in the provided document.
The document is a regulatory letter from the FDA to OmniGrace (Thailand) Ltd. regarding the clearance of their examination gloves, confirming their substantial equivalence to already marketed devices. It focuses on regulatory compliance rather than performance study results.
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