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Note - These Surgical Respirator does not come with adjustable fastener*
PROUDLY MADE IN SINGAPORE with Protection Class of CE Certified FFP3 & FFP2; N95 & KN95, novita Surgical Respirators are produced through the best possible quality and standards. Tested by accredited testing laboratories in U.S., Europe, China and Singapore and in compliance to European Union Directives and Regulations, novita CE Certified Surgical Respirators are backed with proven filtration efficiency of ≥99.70% against 0.1 micron particle, ≥99.80% against oil aerosol, 99.95% against bacteria and passed the synthetic blood penetration test at 120 mmHg as per ASTM F1862-17 for effective fluid resistance. novita Surgical Respirators R7, R5 & R2, designed for maximum protection with breathable comfort for you and your loved ones!
Everyone should be concerned about the air around us since air pollutants can cause a variety of health problems and are especially harmful to young children, old folks and those with pre-existing respiratory conditions. The importance of air quality is obvious as we take in approximately 26,000 breaths, which is equivalent to about 800 oxygen tanks every day.
The biggest hazard of the haze is the Particulate Matter PM2.5, which can be easily inhaled into our lungs arising to acute symptoms such as cough, wheezing, shortness of breath and a feeling of tiredness and weakness. Long-term exposure may lead to the development of underlying medical conditions.
Pathogenic airborne bacteria could be responsible for a variety of respiratory infections and infectious diseases. These airborne bacteria gain access to the body’s tissues, commonly from mouth and nose and those with weaker immunity or with pre-existing medical conditions will be more susceptible to the invasion.
Dust particles are solids suspended in the air. The smaller the particle, the longer it will stay airborne. This would increase the likelihood of inhaling it into the respiratory passages and increase the risk of respiratory conditions.
The biggest hazard of the haze is the Particulate Matter PM2.5, which can be easily inhaled into our lungs arising to acute symptoms such as cough, wheezing, shortness of breath and a feeling of tiredness and weakness. Long-term exposure may lead to the development of underlying medical conditions.
Pathogenic airborne bacteria could be responsible for a variety of respiratory infections and infectious diseases. These airborne bacteria gain access to the body’s tissues, commonly from mouth and nose and those with weaker immunity or with pre-existing medical conditions will be more susceptible to the invasion.
Dust particles are solids suspended in the air. The smaller the particle, the longer it will stay airborne. This would increase the likelihood of inhaling it into the respiratory passages and increase the risk of respiratory conditions.
| Protection Class | Test Standard | Testing Bodies | Certifications |
| N95 Protection Class | NIOSH-42C FR84 | USA Accredited Lab | NIOSH Certification In Process |
| FDA Recognized Consensus Standards | ASTM F2100-19 | Singapore Accredited Lab | ASTM |
| FFP3 Protection Class | EN149:2001 | Poland Accredited Lab | CE Certified |
| FFP2 Protection Class | EN149:2001 | Poland Accredited Lab | CE Certified |
| KN95 certified | GB2626-2006 | China Intertek | - |
| FDA Recognized Consensus Standards | ASTM F1862-17 | Singapore Accredited Lab | ASTM |
FILTRATION PERFORMANCE TEST
Tested in accordance to 42 CFR Part 84.180, the air exchange differential was measured for the inhalation and exhalation resistance with NIOSH procedure. novita Surgical respirators have conformed to this NIOSH criterion for airflow resistance, ensuring wearer’s breathability comfort.
Tested in accordance to ASTM F2101-19, FDA Recognized Consensus Standards, novita Surgical Respirator is capable of retaining up to 99.95% of biological aerosol.
Tested in accordance to 42 CFR Part 84 and TEB-APR-STP-0059 for requirements on a N95 respirator. Achieving ≥ 98.79% filtration efficiency against 0.3 micron sodium chloride (NaCl) particulate aerosol, surpassing the minimum efficiency of ≥95%.
Tested by Singapore Accredited Lab, novita Surgical respirator attains remarkable filtration efficiency of up to 100% against a range of particle from PM0.1 to PM5.0 in size, providing you and your loved ones with maximum protection.
Tested in accordance to EN149:2001+A1:2009 standard, novita Surgical Respirator R5 meets the FFP2 requirement for Sodium Chlorine Test at 95 l/min with remarkable results as high as 99.84% filtration efficiency.
Tested in accordance to EN149:2001+A1:2009 standard, novita Surgical Respirator R5 meets the FFP2 requirement for Paraffin oil test at 95 l/min with outstanding result as high as 99.72% filtration efficiency.
Tested in accordance to EN149:2001+A1:2009 standard, novita Surgical Respirator R7 meets the highest filtration performance of FFP3 for the particle filtration efficiency sodium chlorine test, achieving almost 100% filtration efficiency.
Tested in accordance to EN149:2001+A1:2009 standard, novita Surgical Respirator R7 meets the highest filtration performance of FFP3 for the particle filtration efficiency paraffin oil test, achieving as high as 99.90% filtration efficiency.
MATERIAL PROPERTIES TEST
ASTM F1862-17 Standard, the novita Surgical Respirator has passed the 120 mmHg high-velocity stream of synthetic blood fluid resistance test to provide complete protection with breathable comfort.
Tested in accordance to ASTM F2100-19, novita Surgical Respirator material does not ignite and passed the Flammability Test requirements specified in 16 CFR Part 1610.
FEATURES
Secure one side of the ear loop by sliding it into the circle opening of the fastener.
Put on the surgical respirator, adjust and hook the other ear loop onto the opposite end of the fastener with 3 fitting options.
Allow the fastener to rest comfortably at the back of the head.
Slot the top headband into the left and right slits of the adjustable fastener. Leave some headband allowance between the 2 slits to form a pulling loop as illustrated.
Put on the Surgical Respirator and allow the adjustable fastener to rest comfortably at the back of the head. To tighten the headband, secure the adjustable fastener and pull the headband loop.
Flip the surgical respirator inside out. Align the adhesive onto the nose bridge area. Paste it on as per illustrated.
SURGICAL
RESPIRATOR R2 EARBAND
Conformity to Quality Management System (QMS): ISO13485
Licensed by Health Science Authority of Singapore as Class A medical device manufacturer, our high-speed fully automated production facilities and processes are in conformity to Quality Management System (QMS): ISO13485, adhering to stringent quality and production controls.
QUALITY ASSURANCE. PRODUCT CONSISTENCY. PROVEN EFFICIENCY
Placing utmost priority on all stages of the manufacturing process, we produce and supply quality-driven surgical respirators to our valued business partners worldwide. Going into every detail with meticulous attention and precision, we strive to maintain the highest possible product quality standard to ensure customer’s satisfaction and quality assurance.
8-Piece / 12-Piece / 20-Piece / 100-Piece
CE certified, novita Surgical Respirator R7 graded with protection class of FFP3, the highest European Union disposable filtering half mask standards, to provide you with the highest level of protection! This ergonomically close facial fit and secure seal Surgical Respirator is tested by accredited testing laboratories in Europe, China and Singapore and in compliance to European Union Directives and Regulations. Backed with proven filtration efficiency of ≥99.70% against 0.1 micron particle, ≥99.80% against oil aerosol, 99.95% against bacteria and passed the synthetic blood penetration test at 120 mmHg as per ASTM F1862-17, novita FFP3 Surgical Respirator R7 is composed of high efficiency and low air resistance 5-ply filter layers to reduce the inhalation exposure of harmful airborne contaminants and provide fluid resistance for maximum protection with breathable comfort for you and your loved ones!
*Note: Adjustable fastener is only applicable for surgical respirator R7 & R5 headband.
CE Certified, novita Surgical Respirator R5 with protection class FFP2 is ergonomically designed with a close facial fit and secure seal to achieve ≥99.89% filtration efficiency against 0.1 micron particle, ≥98.21% against oil aerosol, 99.95% against bacteria and passed the synthetic blood penetration test at 120 mmHg as per ASTM F1862-17. Composed of 5 ply filter layers, it helps to reduce inhalation exposures to harmful airborne contaminants and provide fluid resistance for complete protection and quality assurance.
*Note: Fastener is only applicable for surgical respirator R5 earband.
Equipped with protection class N95 & KN95, novita Surgical Respirator R2 is composed of 4-ply filter layers to achieve ≥98.79% filtration efficiency against 0.3 micron particle and 99.95% filtration efficiency against bacteria. Qualified as Surgical Respirator, it passed the synthetic blood penetration test at 120 mmHg as per ASTM F1862-17 to proof its effective protection by reducing inhalation exposure to harmful airborne contaminants. Available in both earband and headband options wearer selection.
