510(k) clearance

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

FDA 510(k) source

510(k) number

K260794

Applicant

Kossan International Sdn Bhd

Decision date

Aug 18, 2026

Date received

Mar 11, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

LZA

Device type

Polymer Patient Examination Glove

Device class

Class I

Regulation

21 CFR 880.6250

Advisory committee

General Hospital

Statement or summary

Statement

Third party

N

Location

Shah Alam, MY