(253 days)
The PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves are radiation attenuating and intended to be worn by operating room personnel to protect a surgical wound from contamination.
PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves Model 1: 0.22mm Model 2: 0.30mm
This document is a 510(k) clearance letter from the FDA for surgical gloves and an "Indications for Use" statement. It does not contain any information about acceptance criteria or a study proving that a device meets those criteria.
The prompt asks for details related to acceptance criteria, device performance, study design (sample size, data provenance, ground truth establishment, MRMC studies, standalone studies), and expert qualifications, which are typical for studies supporting the effectiveness or substantial equivalence of diagnostic or AI-powered devices.
Since the provided text is for surgical gloves, which are general hospital devices and not diagnostic or AI-powered, these detailed study requirements are not applicable to the documentation provided. The 510(k) process for surgical gloves focuses on demonstrating substantial equivalence to a predicate device, primarily through material properties, manufacturing standards, and performance characteristics like barrier integrity, rather than complex clinical studies involving ground truth and expert consensus for interpretation.
§ 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).