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DEVICE DETAILS

NAME OF DEVICEDisposable Surgical Face Mask
ESTABLISHMENT NAMEKOMARK MASK (M) SDN BHD
REGISTRATION NOGA5189323-129687
BRAND NAMEKomark Mask
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONSurgical Disposable Face Mask is an effective form PPE to provide respiratory protection and can prevent the transmission of contagious respiratory droplets by infected individuals. Product Description: • Particulate Matter rating, PM 0.1 • Bacterial Filtration Efficiency, BFE ≥98% • Particle Filtration Efficiency, PFE ≥98% • Viral Filtration Efficiency, VFE ≥99% • Synthetic Blood Splash Resistance, 160mmHg • Flammability, Class 1 There are two type: Tie On Disposable Surgical Face Mask and Ear Loop Disposable Surgical Face Mask. Sterilized by ethylene oxide. Disposable and single use.
DEVICE INTENDED PURPOSEThe surgical disposable face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluid and particulate material. Surgical face mask also used for infection control practices to reduce the potential exposure to blood and body fluid.
VALIDITY DATE OF REGISTRATION08/05/2023 - 07/05/2028

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Disposable surgical face maskFMS3PA-TO
2Disposable surgical face maskFMS3PA-TO
3Disposable surgical face maskFMS3PA-TO
4Disposable surgical face maskFMS3PA-TO
5Disposable surgical face maskFMS3PA-TO
6Disposable surgical face maskFMS3PA-EL
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