(50 days)
LAGLOVE™ 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.
LAGLOVE™ Brand Latex Surgical Gloves - Sterile (Powder Free) Containing 50 ugm or less of water Extractable protein per gram.
This document is a 510(k) premarket notification approval letter from the FDA for Laglove™ Powder Free Latex Surgical Gloves. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way a clinical study report for an AI/ML device would.
The letter approves the device for marketing based on "substantial equivalence" to a predicate device. This means the FDA has determined the new device is as safe and effective as a legally marketed device. The "indications for use" (page 2) describe the intended purpose of the gloves, but these are not performance acceptance criteria.
Therefore, I cannot provide the requested information from this document. To answer your questions, I would need a different type of document, such as a study report or a technical performance specification for an AI/ML device.
§ 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).