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A Surgeons glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

POWDERFREE LATEX MICROSURGERY GLOVES BROWN COLOR

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving device performance. The document is a 510(k) premarket notification letter from the FDA to Primus Gloves Private Limited regarding their Powder Free Latex Microsurgery Gloves. It states that the device has been found substantially equivalent to legally marketed predicate devices and outlines the general controls and regulations the company must adhere to.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used.
8. Training set sample size.
9. How ground truth for the training set was established.

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A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination

Pre-Powdered Sterile Latex Surgeon's Gloves (Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram)

The provided text is related to the FDA 510(k) premarket notification for "Pre-Powdered Sterile Latex Surgeon's Gloves." It's a regulatory document confirming substantial equivalence to a predicate device, not a study report detailing acceptance criteria and performance of a new device in the context of AI/software or medical imaging.

Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance for a device proving it meets acceptance criteria cannot be extracted from this document.

This document specifically grants clearance based on the substantial equivalence of the described gloves to existing legally marketed devices, under the regulation 878.4460 for Surgeon's Gloves, product code KGO. It does not contain an independent technical study or performance evaluation with the kind of metrics you've asked for.

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A Vinyl examination glove sterile powdered is a disposable device made of polyvinyl chloride paste resin that bears powder to facilitate donning and is intended to be worn on the hands, for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

A Vinyl examination glove sterile powdered is a disposable device made of polyvinyl chloride paste resin that bears powder to facilitate donning and is intended to be worn on the hands, for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

This document is a 510(k) premarket notification letter from the FDA regarding "Vinyl Examination Gloves, Sterile Powdered." It is a regulatory approval, not a study report or clinical trial. Therefore, it does not contain the information requested about acceptance criteria and study details for a device's performance.

To answer your request, a document detailing performance testing, clinical studies, or an substantial equivalence report would be needed. This letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices.

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