(40 days)
BRIGHTWAY™ Brand Latex Surgical Gloves - Sterile (Powdered), containing 150 µgm or less of water extractable protein per gram is a disposable glove made of Natural Rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Not Found
This document is a 510(k) clearance letter from the FDA for "BRIGHTWAY™ Brand Latex Surgical Gloves - Sterile (Powdered)". It is a regulatory approval document and does not contain the requested information about acceptance criteria or a study proving the device meets those criteria.
The document only states the device's intended use and that it is substantially equivalent to legally marketed predicate devices. It also mentions a specific parameter: "containing 150 µgm or less of water extractable protein per gram." While this is a characteristic of the device, the document does not present it as an acceptance criterion from a study or provide any study details.
Therefore, I cannot fulfill the request as the necessary information is not present in the provided text.
§ 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).