(264 days)
Sterile Powder-Free Synthetic Rubber Surgeon's Glove with Low Dermatitis Potential is a single use disposable device intended to be worn by operating room personnel to protect a surgical wound from contamination.
Sterile Powder-Free Synthetic Rubber Surgeon's Glove with Low Dermatitis Potential
The provided text is a 510(k) Premarket Notification clearance letter for a medical device: "Sterile Powder-Free Synthetic Rubber Surgeon's Glove with Low Dermatitis Potential." This document does not contain any information regarding the acceptance criteria, study details, or performance metrics for a software-based medical device or an AI/ML algorithm.
The information requested in the prompt (acceptance criteria, study design, sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, training set details) is typically associated with the evaluation of AI/ML-powered diagnostic or prognostic devices. Since the provided document describes a physical medical device (surgical gloves), these specific data points are not present.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer any of the subsequent detailed questions about study design, experts, or AI/ML performance based on 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).