DEVICE DETAILS
| NAME OF DEVICE | UCARE KN95 RESPIRATOR |
|---|---|
| ESTABLISHMENT NAME | UPA HEALTHCARE PRODUCTS SDN. BHD. |
| ROLE OF ESTABLISHMENT | MANUFACTURER |
| REGISTRATION NO | GA2781921-66738 |
| BRAND NAME | UCARE |
| MEDICAL DEVICE CATEGORY | SINGLE-USE DEVICES |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | A form-shaped filtering mask designed to be placed over the nose and mouth of a member of the general public to permit normal breathing while protecting the wearer from large particles (e.g., blood, body fluids, and airborne particulate materials) and small particles (e.g., bacteria and viruses) when considered necessary (e.g., viral epidemic). It is typically made of multiple layers of non-woven polymers to produce a soft, flexible mask that will create an airtight seal against the user’s face and typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device. |
| DEVICE INTENDED PURPOSE | A form-shaped filtering mask designed to be placed over the nose and mouth of a member of the general public to permit normal breathing while protecting the wearer from large particles (e.g., blood, body fluids, and airborne particulate materials) and small particles (e.g., bacteria and viruses) when considered necessary (e.g., viral epidemic). It is typically made of multiple layers of non-woven polymers to produce a soft, flexible mask that will create an airtight seal against the user’s face and typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device. |
| VALIDITY DATE OF REGISTRATION | 16/07/2021 - 15/07/2026 |