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DEVICE DETAILS

NAME OF DEVICEHEADLOOP SURGICAL FACE MASK
ESTABLISHMENT NAMEROCKY SCIENTIFIC INSTRUMENTATION
REGISTRATION NOGA6265621-80554
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 used inside the operating room to protect the patient environment from contamination. It is also intended to protect the wearer against splashes of potentially contaminated liquids
VALIDITY DATE OF REGISTRATION06/12/2021 - 05/12/2026

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1HEADLOOP SURGICAL FACE MASKFTF008
2HEADLOOP SURGICAL FACE MASKFTF007
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