(69 days)
The surgical glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination between the patient and the surgeon.
LATEX SURGICAL POWDERFREE GLOVES
This document is a 510(k) clearance letter from the FDA for powder-free latex sterile surgical gloves. It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The letter approves the marketing of the device based on its substantial equivalence to a predicate device. Therefore, I cannot provide the requested information.
§ 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).