(154 days)
This surgeon's glove is a device made of Flexylon intended to be worn by operating room personnel to protect a surgical wound from contamination.
Flexylon; a styrene-ethylene/butylene-styrene (SEBS) material.
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for "Finessis Corium Flexylon Powder Free Sterile Green Surgical Gloves," along with an "Indications for Use" statement.
The document states that the device is "substantially equivalent" to legally marketed predicate devices, but it does not detail:
- Specific acceptance criteria (e.g., tensile strength, puncture resistance, barrier integrity) for the gloves.
- Results from a study proving the device meets these criteria.
- Sample size, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from any such study.
The letter explicitly states, "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act." This implies that while the device is cleared for market based on equivalence, the detailed performance study information requested is not provided in this regulatory 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).