TECH SPECS & TEST RESULTS VOGMASK
TECH SPECS & TEST RESULTS
Vogmask is NOT classified as Masks to prevent disease – Regulated under CDRH/FDA as Class II medical devices subject to premarket notification 510(k), classified as surgical mask 21 CFR 878.4040. Surgical masks are not PPE, they protect the patient and the surgical area from contamination. Surgical masks prevent droplets being expelled into the environment by the wearer and protect patients in surgery from these being transferred to the operative site.
Vogmask excels in Quantitative and Qualitative Fit Testing across a wide variety of face shapes.
Material Specifications : Vogmask – Microfiber N99 CV
Stylish shape and design for happy mask wearing.
Respirators are PPE and are designed and used to reduce the potential exposure of the wearer to airborne hazardous contaminants.
- Particle filtering half mask to reduce exposures to airborne particulate matter.
- Helps to protect from non-oil airborne particles such as dust, pollen, shavings, and
- The mask can also help reduce exposures to airborne biological particles such as
- Intended for general public use.
- Follow fitting instructions carefully; filtering efficiency depends on proper fitting.
- Do not use Vogmask for chemicals gases, vapors, oils, aerosols, oil based particles,
- Does not eliminate the risk of illness, diseases, or infection.
- Leakage will occur if facial hair passes under the face seal.
- This product does not guarantee protection from illness or any harmful substance.
CE CERTIFIED PRODUCT FAMILIES
Vogmasks are available in two CE Certified Product Families: Microfiber N99CV and N99 Organics.
N99CV Vogmasks are printed microfiber outer layer, N99 particle filtering media, carbon filter, and one exhalation valve for facilitating exit of moisture and CO2 from the interior of the mask.
N99 and N99C2V Organic Vogmasks are solid color dyed outer layer organic cotton, N99 particle filtering media, carbon filter, and (N99C2V) two exhalation valves for facilitating exit of moisture and CO2 from the interior of the mask.
CE CERTIFICATES: RESPIRATORY PROTECTIVE EQUIPMENT
The CE Mark is awarded after submission of Technical File including Quality Management System for Conforming Products, Material Safety Data Sheets on components, and Testing and Assessment on the Product Family, Vogmask N99CV (valved respirators) and Vogmask N99 Organic (no valve and 2 valve).
KF-94 Korean Ministry of Food and Drug Safety, Seoul, Korea KN-94.
Filtering efficiency meets filtering limits of 94% of particles over .3 microns.
KN95 CHINA PERSONAL PROTECTIVE EQUIPMENT
National Quality Supervision for Personal Protection Equipment
Filtering efficiency meets filtering limits of 95% of particles over .3 microns.
N99 Particle Penetration Filtering Efficiency
The NIOSH N99 filter efficiency as stated in 42 CFR Part 84.181 is a minimum efficiency for each filter of ≥ 99% ( ≤ 1% penetration) . The test articles submitted by the sponsor conform to the NIOSH N99 criteria for filter efficiency.