Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate +1 more— 510(k) K260558

Name: FDA 510(k) clearance K260558
Creator: U.S. Food and Drug Administration
Published: 2026-07-28

Substantially Equivalent

Hartalega NGC Sdn. Bhd.

FDA 510(k) clearance K260558 for Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate +1 more, Substantially Equivalent on 2026-07-28. Applicant: Hartalega NGC Sdn. Bhd.. Device class: 1.

Summary

Hartalega NGC's clearance covers two latex powder-free surgical gloves, one with colloidal oatmeal, filed under KGO, surgeon's gloves. Both names say the gloves were tested for use with chemotherapy drugs and fentanyl citrate; the record doesn't list the drugs or give results.

Class I, 21 CFR 878.4460. The General Hospital review panel handled it as a Traditional 510(k), though the record lists General and Plastic Surgery as the classification panel.

Hartalega filed from Sepang, Malaysia. The decision came 159 calendar days after receipt (February 19 to July 28, 2026).

Clearance details

Device name as filed: 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.
Product code: Product code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 2026-02-19
Decision date: 2026-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sepang, MY

Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate +1 more— 510(k) K260558

Summary

Clearance details

Recent devices under product code KGO

More clearances from Hartalega NGC Sdn. Bhd.