Mask, surgical, single use
Access comprehensive regulatory information for Mask, surgical, single use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Dexcon Pty Ltd, manufactured by Tecomen Technology Co Ltd in Vietnam. The device registration started on September 16, 2020.
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.
Product description: single use Four ply medical Type II R (certified Level 3) face mask with elastic ear loop individually pack. The purpose of the products are to stop the transmission of bacterial virus pollen into humans respiratory system. Greater Than >98% filtration rate with filter made from melt blown fabric. Other 3 layers are made from Non-Woven material fabric. Products are made to comply with Australia standards 4381:2015, and are classified as Level 3 Type II R barrier medical face mask. Materials are evaluated for resistance to penetration by synthetic blood at the maximum velocity, bacterial filtration efficiency and differential pressure. Certificate of original of the products can be provided by the manufacture. international certificate such as CE, FDA can also be provided. Test report of above index can also be provided