Australia TGA ARTG recordNitrile examination/treatment glove, non-powdered
Australia TGA ARTG Registered Device · Ultra Health Medical Pty Ltd · Blue Sail Medical Co Ltd · Class I · Started May 06, 2024
Good Name: Ultra Health Medical Pty Ltd - Nitrile examination/treatment glove, non-powdered
- Risk Class
- Class I
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- May 06, 2024
- Effective Date
- May 06, 2024
- Country
- China
- Address
- Qilu Chemical Industrial Park No 21 Qingtian Rd, Zibo, Shandong, 255414
A non-sterile device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with talcum powder. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide 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.
Access comprehensive regulatory information for Nitrile examination/treatment glove, non-powdered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Ultra Health Medical Pty Ltd, manufactured by Blue Sail Medical Co Ltd in China. The device registration started on May 06, 2024.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.