(78 days)
BarrierPlus® Gold Ortho Powder-free Synthetic Polyisoprene Orthopedic Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination.
BarrierPlus® Gold Ortho Powder-free Synthetic Polyisoprene Orthopedic Surgical Glove
The provided text is a 510(k) premarket notification letter from the FDA regarding a surgical glove, not a study report for a diagnostic device or AI algorithm. Therefore, it does not contain the information required to answer your prompt. The document is an approval letter for a medical device (surgical gloves) and discusses regulatory compliance rather than performance studies or acceptance criteria in the context of device accuracy or effectiveness for diagnostic purposes.
Specifically, the document does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or details about the ground truth.
- Information on expert adjudication, MRMC studies, or standalone algorithm performance.
- Details about training sets or how ground truth for training was established.
§ 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).