(155 days)
Sterile Latex Powder-Free Surgical Gloves are sterile disposable devices made of natural rubber latex (that may bear a trace amount of glove powder) and are intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Sterile Latex Powder-Free Surgical Gloves are sterile disposable devices made of natural rubber latex (that may bear a trace amount of glove powder) and are intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
I am sorry to inform you that the provided text is a 510(k) clearance letter from the FDA for Sterile Latex Powder-Free Surgical Gloves.
This document does not contain information about a medical device that utilizes AI or algorithms, nor does it discuss acceptance criteria, study data, or ground truth establishment relevant to AI/ML device performance.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as the document does not contain this type of information. It is a regulatory document for a physical medical device (gloves).
§ 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).