DEVICE DETAILS
NAME OF DEVICE | 3D Medical Face Mask |
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ESTABLISHMENT NAME | XU CARE TRADING |
ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
REGISTRATION NO | GA6275823-148836 |
BRAND NAME | XUCARE |
MEDICAL DEVICE CATEGORY | SINGLE-USE DEVICES |
DEVICE GROUPING TYPE | FAMILY |
DEVICE DESCRIPTION | Face masks are made of 3-ply of water resistant outer layer, non woven filter to filter out the dust and germs, excellent filtering melt blown fabric with electrostatic charge, soft and fine inner non woven skin friendly and suitable for sensitive skin. They have bacterial filtration efficiency and particles filtration efficiency for use by humans in any situation such as pandemic, medical sectors and common use for health concern. A new 3D design for easy talking while using the face mask. |
DEVICE INTENDED PURPOSE | 3 layers filtering face mask respirator and used as to reduce or prevent the transmission of disease. It's single use product and is not recommended for multiple use. It is suitable for wearing by clinical medical personnel during invasive operations and other processes. |
VALIDITY DATE OF REGISTRATION | 27/09/2023 - 26/09/2028 |