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., Molnlycke Health Care Us, LLC and Wembley Rubber Products (M) Sdn Bhd.