(64 days)
LAGLOVE™ Brand Nitrile Surgical Gloves -Sterile (Powdered) is a disposable glove made of synthetic rubber intended to be worn by operating room personnel to provide a barrier against potentially infectious materials and other contaminants.
LAGLOVE™ Brand Nitrile Surgical Gloves -Sterile (Powdered) is a disposable glove made of synthetic rubber.
This document is a 510(k) premarket notification approval letter for the "Laglove™ Brand Nitrile Surgical Glove-Trade Name: Sterile (Powdered)". As such, it does not contain information about acceptance criteria and a study proving a device meets those criteria.
The core purpose of this document is the FDA's declaration of "substantial equivalence" of the device to previously marketed devices, allowing it to be marketed.
Therefore, I cannot provide the requested information from the given text.
§ 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).