ARTG 475291Polychloroprene surgical glove, non-powdered
ARTG ID: 475291 · The Glove Company Pty Ltd · PT Medisafe Technologies · Class IIa · Started January 08, 2025
Good Name: The Glove Company Pty Ltd - Polychloroprene surgical glove, non-powdered
- Risk Class
- Class IIa
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 475291
- Start Date
- January 08, 2025
- Effective Date
- January 08, 2025
- Country
- Indonesia
- Address
- Jl Batang Kuis gg Tambak Rejo/Pasar IX Desa Buntu Bedimbar Tanjung Morawa, Medan, Sumatera Utara, 20362
It is intended to be used once in an invasive procedure involving a single patient and permanently discarded after use. These gloves are worn on the hands of healthcare personnel to provide barrier protection from cross-contamination between patients and healthcare personnel. The healthcare personnel includes surgeons and operation theatre staff. This device is not a measuring device, not used for screening, monitoring, diagnosing, prognosing, prediction or companion diagnostic devices. This medical device is not intended to identify a disorder or define and differentiate it. This medical device is not an automated, qualitative or quantitative device.
Access comprehensive regulatory information for Polychloroprene surgical glove, non-powdered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 475291 and sponsored by The Glove Company Pty Ltd, manufactured by PT Medisafe Technologies in Indonesia. The device registration started on January 08, 2025.
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.