FDA Product Code KGO: Surgeon's Gloves
Under FDA product code KGO, surgeon's gloves are cleared for use during invasive surgical procedures.
These sterile, powdered or powder-free disposable gloves protect both the patient and surgical team from cross-contamination during procedures that penetrate tissue. They are manufactured to precise thickness and barrier standards that exceed those of examination gloves, and are tested for pinholes, elongation, and tensile strength.
KGO devices are Class I medical devices, regulated under 21 CFR 878.4460 and reviewed by the FDA General Hospital panel.
Leading manufacturers include Wrp Asia Pacific Sdn. Bhd., Ansell Healthcare Products, LLC and Hartalega NGC Sdn. Bhd..
List of Surgeon's Gloves devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Surgeon's Gloves devices (product code KGO). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the General Hospital FDA review panel. Browse all General Hospital devices →