FDA cleared the Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl Citrate from Hartalega NGC Sdn. Bhd. on Jul 28, 2026 under K260558, a traditional 510(k). The device falls under product code KGO, Surgeon'S Gloves, regulated at 21 CFR 878.4460 as a Class 1 device. The review panel was General, Plastic Surgery.
FDA logged the submission as received on Feb 19, 2026. The decision came 159 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
Hartalega NGC Sdn. Bhd. has 3 other decisions in the tracker over the last 12 months: K254285 (Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Violet Blue), K260867 (Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)), K250861 (Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black)).