DEVICE DETAILS
| NAME OF DEVICE | PARAGON Surgical Face Mask |
|---|---|
| ESTABLISHMENT NAME | PARAGON MEDICARE SUPPLIES SDN. BHD. |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GA1755920-49371 |
| BRAND NAME | PARAGON |
| MEDICAL DEVICE CATEGORY | SINGLE-USE DEVICES |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | A single-use and non-sterile medical device made of non-woven fabric. It consists of a mask body, a nose clip and ear loops or with ties. The mask body is composed of an inner and outer layer of spun-bond non-woven fabric and the middle layer of melt-blown non-woven fabric with a total of 3 layers. |
| DEVICE INTENDED PURPOSE | It is a device used to cover the mouth and nose. It serves as a barrier for contaminants being released from the mouth of a sick person and spread to the environment or to be inhaled by people in the public. It is used in surgery, medical and dental examinations, industrial sites, general cleaning, preparation of food or worn when airborne diseases caused an outbreak. |
| VALIDITY DATE OF REGISTRATION | 09/11/2020 - 08/11/2025 |