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

510(k) number: K260794
Device name: 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
Applicant: Kossan International Sdn Bhd MY
Product code: LZA — Polymer Patient Examination Glove
Decision date: 2026-08-18
Date received: 2026-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: General Hospital

This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.

Official FDA record: K260794

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.