(139 days)
A powder free nitrile surgical glove is a disposable device intended to be worn on the hands by operating room personnel to provide a barrier against potentially infectious materials and other contaminants.
Sterile Powder Free Nitrile Surgical Gloves
I'm sorry, but based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets those criteria. The provided document is a 510(k) clearance letter from the FDA for Sterile Powder Free Nitrile Surgical Gloves. It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory framework.
The document does not contain any information about:
- Specific acceptance criteria for device performance (e.g., tensile strength, puncture resistance, barrier integrity metrics).
- Any studies conducted to demonstrate the device meets acceptance criteria.
- Sample sizes for test sets, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
- Information regarding multi-reader multi-case studies or standalone algorithm performance.
Therefore, I cannot provide the requested information.
§ 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).