FDA Product Code FMK: Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Single-use lancets with integrated sharps protection represent a significant advance in patient and healthcare worker safety. FDA product code FMK covers disposable blood lancets with integral sharps protection for single use.

These devices have a retractable or permanently shielded blade that is exposed only during the lancing action, preventing needle-stick injuries after use. They are used for capillary blood sampling in glucose monitoring and other point-of-care tests.

FMK devices are Class II medical devices, regulated under 21 CFR 878.4850 and reviewed by the FDA General & Plastic Surgery panel.

Leading manufacturers include Tianjin Huahong Technology Co., Ltd., Promisemed Hangzhou Meditech Co., Ltd. and Owen Mumford, Ltd..