Device Dossier

Hevea-latex surgical glove, non-powdered

Device Dossier for Hevea-latex surgical glove, non-powdered (Hevea-latex surgical glove, non-powdered, Class IIa, sponsor Ultra Health Medical). ARTG…

Intended purpose

A sterile device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; its inner surface is not covered with talcum powder. The device is used mainly as a two-way barrier to protect both the patient and the staff against contamination from microorganisms. It will have appropriate characteristics regarding tactility and comfort of use, and should provide adequate conditions of sterility, appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

TGA Public Summary