K260558

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

510(k) number: K260558
Device name: 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
Applicant: Hartalega NGC Sdn. Bhd. MY
Product code: KGO — Surgeon'S Gloves
Decision date: 2026-07-28
Date received: 2026-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: General, Plastic Surgery

PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain

Also available from FDA: K260558.pdf

Official FDA record: K260558

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