(30 days)
The surgeon's gloves are sterile gloves to be worn by surqeons, healthcare workers or similar personnel during surgical procedures to prevent contamination between the user and the patient.
Latex Surgical Gloves Powdered, Sterile.
The provided document is an FDA 510(k) clearance letter for "Latex Surgical Gloves Powdered, Sterile." It determines substantial equivalence for a medical device but does not contain information about acceptance criteria, efficacy studies, or device performance metrics typically associated with AI/ML-driven diagnostics or complex medical devices.
Therefore, I cannot answer the questions regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided text. The document is primarily regulatory correspondence.
§ 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).