Vogmask is Certified European Community Directive 89/686/EEC (Personal Protective Equipment Directive) with CE Mark EN149:2001 +A1:2009, Korean Ministry of Food and Drug Safety Certified KF94, GB2626-2006 Personal Protective Equipment Certified KN95, and conforms to NIOSH N99 filtering efficiency as stated in 42 CFR Part 84.181.
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.
Certification under Article 10, EC Type-Examination and Article 11, EC quality control, has been issued for these products by BSI, Kitemark Court, Davy Avenue, Knowlhill Milton Keynes, MK5 8PP UK (Notified Body number 0086)
Vogmask is Korean Ministry of Food and Drug Safety Certified, GB2626-2006 Personal Protective Equipment KN95 Certified, and AWARDED CE Mark Personal Protective Equipment - filtering half masks for particles, against EN 149:2001 + A1:2009 for EU market. Vogmask conforms to NIOSH N99 filter efficiency as stated in 42 CFR Part 84.181.
Vogmask excels in Quantitative and Qualitative Fit Testing across a wide variety of face shapes.
Material Specifications : Vogmask – Microfiber N99 CV
Outer layer Faceblank of non woven microfiber
Print design on outer layer Faceblank by thermal transfer
Filter media of Nanofiber PP Filtering Textile middle layer
Filter layer of Active Carbon coconut shell derived charcoal bonded to textile
Exhalation Valve of ABS Resin with silicone stopper
Nosebridge of coated aluminum wire
Trim and ear loops of latex-free spandex
Inner layer Faceblank (comfort inner layer closest to lips) of woven microfiber
Head harness accessory (optional) of Cotton (94%) and Polyurethane (6%) with snaps and tensioner bead, attaches to ear loops
Vogmask is manufactured under Three-tiered Quality Plan for consistency of finished goods.
Engineered to be the most comfortable, best fitting masks in the world.
Features a three-dimensional mask design which allows space for your lips and mouth. The mask is secured to the face with latex free spandex, stretchable ear loops and mask trim for the most comfortable fit of any particle mask. A bendable aluminum noseband provides a secure seal over the bridge of the nose.
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.
The following is a functional description of the Vogmask and its intended use:
- 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
particles found in air pollution.
- The mask can also help reduce exposures to airborne biological particles such as
- Intended for general public use.
Certain limitations apply to the use of the Vogmask product:
- Follow fitting instructions carefully; filtering efficiency depends on proper fitting.
- Do not use Vogmask for chemicals gases, vapors, oils, aerosols, oil based particles,
or extremely high particle concentrations.
- Do not use in oxygen deficient or explosive atmospheres.
- 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.
-This product does not filter gases and particles <0,3 micrometer found in air
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.