Polyisoprene surgical glove, non-powdered

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Tillgänglig från:

Mediflex Industries Pty Ltd

Klass:

Class IIa

Tillverkad av:

Wear Safe (Malaysia) Sdn Bhd Lot 5068 & 5069 Batu 41/2 Jalan Meru, Klang, Selangor Darul Ehsan, 41050 Malaysia

Terapiområde:

56293 - Polyisoprene surgical glove, non-powdered

Terapeutiska indikationer:

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.

Bemyndigande status:

A

Tillstånd datum:

2018-02-20