(180 days)
A surgeon's glove is device made of natural or synthetic rubber intended to be worn by the operating room personnel to protect a surgical wound from contamination.
A surgeon's glove is device made of natural or synthetic rubber intended to be worn by the operating room personnel to protect a surgical wound from contamination.
This document is a 510(k) clearance letter from the FDA for Uniject Powdered Latex Surgical Gloves (K970160). It declares the device substantially equivalent to pre-amendment devices. It describes the device's indications for use: "A surgeon's glove is device made of natural or synthetic rubber intended to be worn by the operating room personnel to protect a surgical wound from contamination."
However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement. These details would typically be found in the 510(k) submission itself, not in the clearance letter.
Therefore, I cannot provide the requested table and information based on the provided 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).