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A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powdered Green Latex Examination Gloves (Polymer Coated)

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for "Powdered Green Latex Examination Gloves (Polymer Coated)."

It states that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. However, it does not include details about specific performance acceptance criteria or a study that rigorously demonstrates the device meets those criteria. The letter primarily focuses on regulatory approval based on substantial equivalence, rather than providing a detailed technical study report.

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A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powderfree Green Latex Examination Gloves

The provided document is a 510(k) premarket notification letter from the FDA regarding "Powder-Free Green Latex Examination Gloves." This document does not contain any information about acceptance criteria for a device, performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information. The document is solely an FDA clearance letter for a medical device that determines substantial equivalence to a predicate device.

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A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powderfree Green Latex Examination Gloves ( Polymer Coated )

This is an FDA Premarket Notification (510(k)) for "Powderfree Latex Examination Gloves (Polymer Coated)". This document is an approval letter and does not contain details about acceptance criteria or a study proving device performance.

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

Ask a specific question about this device

A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powderfree Green Latex Examination Gloves

I'm sorry, but I cannot fulfill your request. The provided text is a letter from the FDA regarding a 510(k) premarket notification for "Powderfree Green Latex Examination Gloves." It confirms the device's substantial equivalence to a predicate device and allows it to be marketed.

This document does not contain any information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies (MRMC or standalone). These are typically found in the 510(k) summary or detailed test reports, not in the FDA's clearance letter itself.

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

Ask a specific question about this device