Questions and answers
What is a transparent mask?
The only transparent mask manufactured in Israel with the approval of the Ministry of Health.
The mask allows for human interaction between the mask wearer and the environment.
Especially suitable for service providers, teachers, therapists, deaf and anyone who comes in contact with an audience.
What is the difference between a respirator and a surgical mask?
The role of a surgical mask and a respirator is completely different and in fact opposite.
The surgical mask is designed to prevent the passage of particles from the person wearing it, so that it does not infect the environment in which it is in bacteria (BFE).
A surgical mask is not airtight and is not considered safety equipment (PPE).
On the contrary, the function of the respirator is to protect its wearer from 0.3 micron particles carried in the air, and it operates under a particularly stringent American standard.
What is N95 respirator and surgical mask?
A mask that meets the N95 standard is an air filtration mask that is applied to the face.
The standard indicates that the mask filters at least 95% of the existing particulate matter in the air, but it is not resistant to oils.
The standard is set by the U.S. Director of Occupational Safety and Health NIOSH.
The filtering mechanism of the mask is based on a mechanical air filter.
A thin mesh of synthetic polymer fibers called "non-woven polypropylene" is required to make a N95 standard mask.
This mesh forms the inner filter layer that prevents the passage of hazardous particles.
What is the ISO 13485 standard for medical equipment according to which the plant operates?
ISO 13485 for medical devices is an international standard for managing a quality systems in organizations that manufacture medical devices.
The main requirements of the standard include:
Implementation of a quality management system with an emphasis on operation and control, necessary for medical products.
Access to risk management for product development and implementation.
Process validation.
Compliance with the requirements of regulations.
Efficient systems of tracking products.
What is the FIT test requirement?
The "FIT" requirement is a regulatory requirement that came from the field of safety and employment, the American NIOSH, which requires that every worker who wears the N95 mask in a polluted environment performs an annual inspection to make sure that the mask is indeed opaque.
This test is performed by professional equipment that examines the amount of particles in the air against the amount of particles in the mask when the mask wearer is asked to perform a number of actions that simulate routine activity to ensure complete sealing.