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..
FDA 510(k) Cleared Surgeon's Gloves Devices (Product Code KGO)
About Product Code KGO - Regulatory Context
510(k) Submission Activity
558 total 510(k) submissions under product code KGO since 1976, with 558 receiving FDA clearance (average review time: 125 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 20 in the prior period.
FDA Review Time
Recent submissions under KGO have taken an average of 176 days to reach a decision - up from 125 days historically. Manufacturers should account for longer review timelines in current project planning.
KGO devices are reviewed by the General Hospital panel. Browse all General Hospital devices →