(204 days)
This Powdered Latex Surgical Glove is a disposable device made of natural rubber latex material that bears powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical setting, to provide a barner against potentially infectious materials and other contaminants.
Powdered Latex Surgeon's Glove
This is a 510(k) premarket notification for a powdered latex surgeon's glove. It is a traditional medical device submission and does not describe AI/ML software. Therefore, I cannot provide the requested information about acceptance criteria, study details, and AI/ML specific aspects.
The document discusses the regulatory classification of the device (Class I), general controls provisions, and the FDA's determination of substantial equivalence to legally marketed predicate devices. It also lists the "Indications for Use" for the glove, stating its purpose as a barrier against infectious materials in a surgical setting.
§ 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).