(32 days)
A surgeon's glove is intended to be worn on the hands of operating room personnel to prevent contamination between such personnel and the patient during a surgical procedure.
Safeskin® PFS PLUS powder-free latex surgical gloves are sterile disposable devices intended to be worn by operating room personnel to prevent contamination between such personnel and the patient during a surgical procedure.
I am sorry, but I cannot provide information on the acceptance criteria or study details regarding the performance of the device based on the provided document. The document is a 510(k) summary and FDA clearance letter for a medical device (Safeskin® PFS PLUS powder-free latex surgical gloves), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study data in the format of acceptance criteria and results.
Specifically, the document states:
- "[8] The performance test data that support a determination of substantial equivalence are described above." This refers to a general statement that the device "Meets ASTM D 3577 Dimensions," "Meets ASTM D 3577 Physical Properties," "Meets ASTM D 3577 Freedom from pinholes," "Meets ASTM D 5151 Powder-Free Less than 2 mg/glove," and "Passes Biocompatability Primary Skin Irritation in Rabbits" and "Passes Guinea Pit Sensitization." However, specific numerical acceptance criteria or the reported device performance values (e.g., exact dimensions, specific tensile strength, etc.) are not provided.
- "[9] Clinical data are not needed for surgical gloves." This indicates that no clinical study was conducted for this submission.
Therefore, I cannot extract the requested information like sample size, ground truth details, expert qualifications, or comparative effectiveness study results from this document.
§ 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).