FDA cleared the Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid from Kossan International Sdn Bhd on Jan 13, 2026 under K252549, a traditional 510(k). The device falls under product code LZA, Polymer Patient Examination Glove, regulated at 21 CFR 880.6250 as a Class 1 device. The review panel was General Hospital.
FDA logged the submission as received on Aug 13, 2025. The decision came 153 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
Kossan International Sdn Bhd has one other decision in the tracker over the last 12 months: K260794 (NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLOR).
Questions & Answers
What did FDA clear under K252549?
K252549 is the FDA 510(k) for Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid, submitted by Kossan International Sdn Bhd. FDA's decision date was Jan 13, 2026, under product code LZA (Polymer Patient Examination Glove).
Who makes the Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid?
Kossan International Sdn Bhd, based in Shah Alam, is the applicant of record for K252549.
How long did the K252549 review take?
FDA received the submission on Aug 13, 2025 and issued its decision on Jan 13, 2026, 153 days later.