DEVICE DETAILS
| NAME OF DEVICE | 4 Ply Premium Medical Face Mask |
|---|---|
| ESTABLISHMENT NAME | THE BEST PERFECT SDN. BHD. |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GA8332722-103631 |
| BRAND NAME | Nine-Care |
| MEDICAL DEVICE CATEGORY | SINGLE-USE DEVICES |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | The product is made of melt-blown filter fabric with BFE (Bacterial Filtration Efficiency) ≥ 99% which is is used to protect both patient and other persons to reduce the risk of spread of infections particularly in epidemic or pandemic situations, and to protect healthcare workers from transfer of microorganisms, body fluids and particle matter. |
| DEVICE INTENDED PURPOSE | A mask is meant to help block large particle droplets, splashes or splatter that may contain germs, keeping it from reaching to your mouth. Face mask may also help to reduce the exposure of your saliva and respiratory secretion to others. This device, is appropriate to be use by healthcare professional during surgical procedures to protect both the patient and healthcare personnel. |
| VALIDITY DATE OF REGISTRATION | 15/09/2022 - 14/09/2027 |