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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 Flex Nitrile Examination Glove, Powder Free
I am sorry, but I cannot provide a table of acceptance criteria and reported device performance or other detailed study information based on the provided text. The documents are FDA 510(k) clearance letters and an "Indications For Use Statement" for an "Omni Flex Nitrile Examination Glove, Powder-Free".
These documents do not contain any information about performance studies, acceptance criteria, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies (MRMC).
The provided text primarily focuses on:
- Regulatory Clearance: The FDA's determination that the device is "substantially equivalent" to legally marketed predicate devices.
- Product Information: Device name, applicant, and intended use (as stated in the "Indications For Use Statement").
- Regulatory Requirements: Mention of general controls provisions, potential additional controls for Class II/III devices, and compliance with Good Manufacturing Practice.
To answer your request, I would need a different type of document, such as a clinical study report, a regulatory submission summary that includes performance data, or a publication detailing the device's validation.
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(63 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 Flex Nitrile Examination Glove, Powder Free, Purple
This document is a 510(k) premarket notification decision letter from the FDA regarding "Omni Nitrile Flex Examination Glove, Powder-Free, Purple." It does not contain information about the acceptance criteria and study proving device performance as requested in the prompt.
Therefore, I cannot extract the requested information from the provided text. The document is a regulatory approval letter, not a scientific study report.
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(50 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent / moundal you between health care personnel and the patient.
Omni Flex Nitrile Examination Glove, Powder Free, Blue
This document is a 510(k) premarket notification letter from the FDA to OmniGrace (Thailand) Ltd. regarding their Omni Flex Nitrile Examination Glove. It is primarily a regulatory approval document and does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance.
The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its approval. However, it does not provide:
- A table of acceptance criteria and reported device performance.
- Details about specific studies (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance, training set size, or how ground truth was established).
The "Indications For Use Statement" only describes the intended purpose of the glove (to prevent contamination between healthcare personnel and the patient) but does not include any performance metrics or study details.
Therefore, I cannot provide the requested information from this document.
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(38 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
Nitrile Examination Glove, Powder Free, Green
The provided document is a 510(k) clearance letter from the FDA for a nitrile examination glove. It does not contain information about acceptance criteria for a device, a study proving the device meets those criteria, or details related to AI/algorithm performance.
Therefore, I cannot extract the requested information as it is not present in the document. The document is primarily a regulatory approval notice for a medical device.
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