(104 days)
The Polymer coated, Powderfree Sterile Surgeon's Glove is to be worn by Operating Room Personnel to protect a Surgical Would from contamination.
POWDERFREE LATEX SURGEON'S GLOVES POLYMER COATED STERILE Contains 50 micrograms or less of Total water extractable protein per gram
I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding "Powder Free Latex Surgeon's Gloves Polymer Coated Sterile". This document is a regulatory approval for a physical medical device (gloves) and does not contain information about a digital medical device, AI, or any study involving acceptance criteria and performance data in the context you've described.
Therefore, I cannot extract the information required in your request about acceptance criteria, study details, sample sizes, ground truth, or MRMC studies for a digital medical device 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).