(154 days)
This surgeon's glove is a device made of Flexylon intended to be worn by operating room personnel to protect a surgical wound from contamination.
FINESSIS ZERO Flexylon Powder Free Sterile White Surgical Glove. Flexylon; a styrene-ethylene/butylene-styrene (SEBS) material.
The provided text is related to an FDA 510(k) clearance for a surgical glove. It describes the clearance of "FINESSIS ZERO Flexylon Powder Free Sterile White Surgical Glove" and states that it has been deemed substantially equivalent to legally marketed predicate devices.
However, the document is a regulatory approval letter and an "Indications for Use" statement. It does not contain any information about acceptance criteria for device performance, or details of a study that proves the device meets those criteria.
Therefore, I cannot provide the requested information from the given input. The document focuses on regulatory approval based on substantial equivalence, not on specific performance data or a study design.
§ 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).