This facility is provided to enable any interested parties to search for Registered Medical Device, Registered CAB, Licensed Establishments under Section 5, 10, 15 of Medical Device Act 2012 (Act 737) respectively and Notified Medical Device under Medical Device (Exemption) Order 2016. Any party who wishes to know whether an establishment who is dealing with medical device has been licensed under Act 737 may search the establishment by inserting the establishment name or license number in the searching field below.


DEVICE DETAILS

NAME OF DEVICESURGICAL FACE MASK
ESTABLISHMENT NAMEROCKY SCIENTIFIC INSTRUMENTATION
REGISTRATION NOGA9474121-80502
BRAND NAMEFRONTIFIE
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONThis surgical face mask offers a moderate barrier protection against fluid exposure and meets the requirements of ASTM Level 2. This Type IIR surgical mask is a surgical grade face mask that includes an outer splash-resistant layer to protect against blood and other bodily fluids. BFE measures the filtration efficiency of a mask using viable (live) particles (bacteria) that vary in size from 5 microns to 1 micron. PFE measures the filtration efficiency of a mask using nonviable (nonliving) particles that are fixed in size from 1 micron to 0.1 microns
DEVICE INTENDED PURPOSEThe Frontifie Surgical Face Mask is like an impenetrable wall that protects you against germs, bacteria and viruses. It is effective against droplets and other contaminants, allowing you to breathe freely while feeling safe and secure to do great things
VALIDITY DATE OF REGISTRATION06/12/2021 - 05/12/2026

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1SURGICAL FACE MASKFTF003
2SURGICAL FACE MASKFTF002
3SURGICAL FACE MASKFTF004