DEVICE DETAILS
NAME OF DEVICE | 3ply Surgical Face Mask |
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ESTABLISHMENT NAME | IMEDIC SUPPLY SDN BHD |
ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
REGISTRATION NO | GA3623222-98283 |
BRAND NAME | I♡Mask |
MEDICAL DEVICE CATEGORY | SINGLE-USE DEVICES |
DEVICE GROUPING TYPE | FAMILY |
DEVICE DESCRIPTION | Three-ply construction for excellent particle and bacterial filtration efficiency. These masks are available with spandex ear loops or polypropylene ties, ultrasonically welded to maintain softness and protect against particulates. An encased, 12cm (4¾”) malleable steel noseband creates a secure facial seal and improves wearer comfort. Latex-free. Packaged 50 masks per pack, 10 packs per case. Mask dimensions: 17.5L x 9.5Hcm |
DEVICE INTENDED PURPOSE | The Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile. |
VALIDITY DATE OF REGISTRATION | 26/07/2022 - 25/07/2027 |