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

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

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

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