DEVICE DETAILS
| NAME OF DEVICE | Iconic Medicare 3D Duckbill 4ply Medical Face Mask |
|---|---|
| ESTABLISHMENT NAME | ICONIC MEDICARE SDN BHD |
| ROLE OF ESTABLISHMENT | MANUFACTURER |
| REGISTRATION NO | GA10731624-161486 |
| BRAND NAME | Iconic Medicare |
| MEDICAL DEVICE CATEGORY | SINGLE-USE DEVICES |
| DEVICE GROUPING TYPE | SINGLE |
| DEVICE DESCRIPTION | Iconic Medicare 3D Duckbill 4ply Medical Face Mask is a medical device, generally composed of a filter layer that is placed, bonded or moulded between layers of fabric. The Medical Face Mask is mainly composed of four layers of non-woven fabric with a pair of elastic ear loop in which being assembled using ultrasonic sewing technology. The face fixation is two elastic ear loops for elimination of gaps between face and mask. The inner layer is a non-woven fabric which made from a hydrophilic non-woven fabric, which is mainly used to absorb the moisture and moisture released by the user(s). The outer layer is a water-resistant polypropylene non-woven fabric, Spunlace Non-woven and PET Non-woven material which is mainly used to protect the wearer against splashes of potentially contaminated liquids. The second and third layer which are the filter layers consists of melt-blown non-woven fabric serves as bacteria and particle filtration layer. This microbial barrier can also be effective in reducing the emission of infective agents from the nose and mouth of an asymptomatic carrier or a patient with clinical symptoms. |
| DEVICE INTENDED PURPOSE | The main intended use of medical face masks is to protect the patient from infective agents and, additionally, in certain circumstances to protect the wearer against splashes of potentially contaminated liquids. 3D Duckbill 4ply medical face masks may also be intended to be worn by patients and other persons to reduce the risk of spread of infections, particularly in epidemic or pandemic situations. |
| VALIDITY DATE OF REGISTRATION | 05/02/2024 - 04/02/2029 |