(126 days)
A powder-free sterile surgeon's glove is a disposable device made of Non-latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Non-latex sterile powder-free surgeon's glove
I'm sorry, but this document does not contain the information requested. This document is a 510(k) clearance letter from the FDA for a non-latex sterile powder-free surgeon's glove. It confirms that the device is substantially equivalent to legally marketed predicate devices.
The document does not include details about:
- Acceptance criteria and reported device performance related to a study.
- Sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
- Any information regarding a multi-reader, multi-case study or standalone algorithm performance.
- Training set details for an algorithm.
This document is a regulatory approval, not a scientific study report.
§ 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).