Polyisoprene surgical glove, non-powdered

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

MAH:

Mediflex Industries Pty Ltd

class:

Class IIa

manufactured_by:

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

therapeutic_area:

56293 - Polyisoprene surgical glove, non-powdered

therapeutic_indication:

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.

authorization_status:

A

authorization_date:

2018-02-20