(60 days)
A Sterile Powdered Latex Surgical Glove is a disposable device made of natural rubber latex and is intended to be worn by operating room personnel to protect a surgical wound from contamination.
Sterile Powdered Latex Surgical Gloves
The provided document is an FDA 510(k) clearance letter for "Maxter Sterile Powdered Latex Surgical Gloves." This document does not contain information about acceptance criteria and a study proving a device meets them in the context of an AI/ML medical device.
The document pertains to a medical device (surgical gloves) that undergoes a different type of regulatory review than AI/ML software. The letter confirms that the device is substantially equivalent to a legally marketed predicate device, primarily based on its materials and intended use, rather than performance metrics derived from complex data analysis.
Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) from this document. This kind of information is typically found in premarket submission summaries for AI/ML devices, not for basic medical consumables like surgical gloves.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).