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DEVICE DETAILS

NAME OF DEVICEICONIC KN99, KF99 AND FFP3 FACE MASK RESPIRATOR
ESTABLISHMENT NAMEICONIC MEDICARE SDN BHD
ROLE OF ESTABLISHMENTMANUFACTURER
REGISTRATION NOGA2745221-76756
BRAND NAMEICONIC MEDICARE
MEDICAL DEVICE CATEGORYSINGLE-USE DEVICES
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONKN99 and KF99 also known as Filtering Face Piece (FFP3), is a disposable protective respirator. KN99 respirators have five layers structure and KF99 have four layers structure and both come with double meltblown protection that are used to protect the wearer from airborne particles and prevent liquid contamination to the face. KN99 has the filtration efficiency of 99% based on Most Penetrating Particle Size (MPPS) with particle size of 0.3 Microns.
DEVICE INTENDED PURPOSEThe main intended use of protective respirator is to protect the patient from infective agents and, additionally, in certain circumstances to protect the wearer against splashes of potentially contaminated liquids. The protective respiration is invented as filtration masks against particles and it is also named as FFP3. FFP3 protective respiration are principally intended for use by healthcare professionals in an operating room or other medical settings with similar requirements. It is suitable for medical, industrial, household and general use. It is effective in preventing the spread of viruses.
VALIDITY DATE OF REGISTRATION24/10/2021 - 23/10/2026

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1ICONIC KN99KN99
2ICONIC KF99KF99
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