DEVICE DETAILS
| NAME OF DEVICE | UCARE KN95 Respirator [Nano Copper Oxide] |
|---|---|
| ESTABLISHMENT NAME | UPA HEALTHCARE PRODUCTS SDN. BHD. |
| ROLE OF ESTABLISHMENT | MANUFACTURER |
| REGISTRATION NO | GA6820022-82886 |
| BRAND NAME | UCARE |
| MEDICAL DEVICE CATEGORY | REUSABLE DEVICES |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | A form-shaped filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the wearer and patient from large particles (e.g., blood, body fluids, and airborne particulate materials) and small particles (e.g., bacteria and viruses) during medical, surgical, dental, and isolation procedures. 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 multiple-use device.It is intended for multiple use by the medical personnel, other general healthcare workers / general public use to protect against the transfer of germs, blood splashes including body fluids, and airborne particulates. |
| DEVICE INTENDED PURPOSE | A form-shaped filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the wearer and patient from large particles (e.g., blood, body fluids, and airborne particulate materials) and small particles (e.g., bacteria and viruses) during medical, surgical, dental, and isolation procedures. 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 multiple-use device.It is intended for multiple use by the medical personnel, other general healthcare workers / general public use to protect against the transfer of germs, blood splashes including body fluids, and airborne particulates. |
| VALIDITY DATE OF REGISTRATION | 12/01/2022 - 11/01/2027 |