Device Dossier
Polyisoprene surgical glove, non-powdered
Device Dossier for Polyisoprene surgical glove, non-powdered (Polyisoprene surgical glove, non-powdered, Class IIa, sponsor Cardinal Health Australia…
- GMDN category: Polyisoprene surgical glove, non-powdered
Intended purpose
A sterile device made of polyisoprene 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. It is used mainly as a two-way barrier to protect patient and staff from microorganisms and risk of allergy to latex. 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.