(37 days)
BRIGHTWAY™ Brand Latex Surgical Gloves - Sterile (Powder Free) containing 50 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.
BRIGHTWAY™ Brand Latex Surgical Gloves - Sterile (Powder Free) Containing 50 ugm or less of water Extractable protein per gram.
This letter is a 510(k) clearance for "Brightway™ Brand Latex Surgical Gloves - Sterile (Powder Free)". It indicates the device is substantially equivalent to legally marketed predicate devices. However, the provided text does not contain any information regarding specific acceptance criteria, study details, or performance data for the gloves.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them because this information is not present in the provided document.
The document is a regulatory approval letter, which confirms the device can be marketed based on its substantial equivalence to another device, but it does not detail the technical performance studies.
§ 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).