(125 days)
A Surgical Glove is a device made of natural or Synthetic rubber, intended to be worn by operating room personnel to protect a surgical wound from contamination.
Sterile Surgical Glove ( POWDERE
This looks like a 510(k) clearance letter for "Digiflex Surgical Gloves (Powdered)". This document does NOT contain information about acceptance criteria or a study proving device performance in the way a diagnostic AI/ML device would.
The document is purely a regulatory letter stating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. The "Indications for Use" section simply defines what a surgical glove is generally used for, not specific performance metrics.
Therefore, I cannot provide the requested information from this document. The questions you've asked are typical for a submission involving diagnostic algorithms or software, not for a physical medical device like surgical gloves.
To answer your request, I would need a document detailing a clinical study or performance validation for a diagnostic device.
§ 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).