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DEVICE DETAILS

NAME OF DEVICEKN95 Surgical Face Mask (Medical)
ESTABLISHMENT NAMESOUTHSIDE MEDICAL SUPPLY SDN. BHD.
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGA4996520-45245
BRAND NAMEZhanJiang Jiahua Pharmaceutical Technology
MEDICAL DEVICE CATEGORYSINGLE-USE DEVICES
DEVICE GROUPING TYPESINGLE
DEVICE DESCRIPTION-KN95 Surgical face mask to be use by healthcare professional during procedures to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. - BFE >95% FFP2 5 -layers surgical & protective mask - Barrier layer: Non-woven fabric blocking large particles - Filtration layer:Melt-blown layer adsorb small particles - Filtration layer: Electrostatic capture of PM0.3 particles
DEVICE INTENDED PURPOSEThis KN95 Surgical Face Mask effectively filters to serve as barrier to potential air pollutants that can be harmful. The face mask’s filtration efficiency of 5 layers will help block out air pollutants like allergens, virus, bacteria, dust, droplets and other harmful non-oil based particles in the air, at least up to 95 percent. It also features an adjustable nose wire to provide proper and comfortable fit to the face contour. This can be use for surgical use medical device.
VALIDITY DATE OF REGISTRATION28/07/2020 - 27/07/2025

LIST OF DEVICE

NONAME OF DEVICEDEVICE IDENTIFIER
1KN95 Surgical Face Mask (Medical)KN95 Surgical Face Mask (Medical)
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