Q: Which is the estimated delivery time of a mask production machine?
The estimated delivery time is 2 months for the surgical mask machines and 3 months for the FFP mask machines.
Q: Do we need to have specialized technicians?
No. You don’t need any specialized technician inhouse because, after the training, this machines can be used by your technicians without any issues.
The diagnostic system is 100% user friendly.
The rare case of jamming or stop of the production are easly resolvable.
Q: How can I get a quotation?
To get a quotation or if you have any question about our products please send us an email to : SALES@BONETTOAUTOMAZIONI.COM .
Q: Is it possible to have a preliminary meeting?
Yes. Jus send us an Email and you will be contacted to set up a meeting and resolve all your initial doubts.
Q: Can I have some informative material?
Yes. You can download the informative material on to the page of the machine you are interested in with the download button: FFP – Surgical
Q: Is it possible to customize the machine?
Yes. It’s possible to customize the machinewith further devices such as automatic packaging, remote assistance service, visual inspection with a camera system and many others.
Q: Where can I get more informations and stay updated about Bonetto’s new projects?
To be always updated please follow us on LInkedin. On our page we will share all the new projects and all the news in the automation’s industry.
MORE INFORMATIONS FROM FDA
Q: Which masks are medical devices regulated by the FDA?
A. Face masks marketed to the general public for general non-medical purposes, such as use in construction and other industrial applications, are not medical devices. Face masks, when they are intended for a medical purpose such as source control (including uses related to COVID-19) and surgical masks are medical devices.
Q: Is there a difference between a mask and a respirator?
A: Masks and respirators both cover a wearer’s nose and mouth, but they differ in several aspects.
Masks are loose fitting and may not provide full protection from breathing in airborne pathogens, such as viruses.
- Face masks (non-surgical masks) may not provide protection from fluids or may not filter particles, needed to protect against pathogens, such as viruses. They are not for surgical use and are not considered personal protective equipment.
- Surgical masks are fluid-resistant, disposable, and loose-fitting devices that create a physical barrier between the mouth and nose of the wearer and the immediate environment. They are for use in surgical settings and do not provide full protection from inhalation of airborne pathogens, such as viruses.
Respirators are personal protective equipment that tightly fit the face and filter airborne particles to protect health care workers. They provide a higher level of protection against viruses and bacteria when properly fit-tested. This document does not address respirators.
This CDC infographic explains the differences between surgical masks and N95 respirators.
Q: I am interested in manufacturing surgical masks for COVID-19. What do I need to do?
During the COVID-19 public health emergency, and as described in the FDA’s policy on face masks and surgical masks that is in effect during the COVID-19 public health emergency, the FDA does not expect manufacturers of surgical masks intended to provide liquid barrier protection to submit notification to the FDA before they begin marketing their product, or to comply with certain regulatory requirements where the surgical masks do not create an undue risk in light of the public health emergency.
Under the policy, the FDA believes surgical masks intended to provide liquid barrier protection do not create an undue risk where:
- The surgical masks meets liquid barrier performance consistent with ASTM F1862 standardExternal Link Disclaimer and the Class I or Class II flammability requirement per 16 CFR Part 1610 (unless labeled with a recommendation against use in the presence of high intensity heath source or flammable gas);
- The surgical masks include labeling that accurately describes the product as a surgical mask and includes a list of the body contacting materials (which do not include any drugs or biologics); and
- The surgical masks are not intended for any use that would create such an undue risk. For example, the labeling does not include uses for antimicrobial or antiviral protection, infection prevention or reduction, or related uses, and does not include particulate filtration claims.
Q: I would like to import masks for COVID-19. What do I need to do?
A: To avoid delays of legitimate shipments, we urge importers to review Importing Supplies for COVID-19 and instructions to importers for important information about importing products, including face masks and surgical masks, to ensure that the proper documentation is submitted at the time of entry. The FDA is ready and available to engage with importers to minimize disruptions during the importing process. If you have questions related to the general importation process, you may email COVID19FDAIMPORTINQUIRIES@fda.hhs.gov. If you have questions regarding an active entry, please contact the FDA office covering your port of entry by visiting the FDA Import Offices and Port of Entry page.
Q: I would like to purchase masks for COVID-19. How do I know if they are counterfeit or fraudulent?
A: The FDA does not issue any kind of certification to demonstrate a manufacturer is in compliance with the FDA’s requirements.
The FDA does not have an exhaustive list of all counterfeit or fraudulent products. To report fraudulent COVID-19 products to the FDA, please email FDA-COVID-19-Fraudulent-Products@fda.hhs.gov.
Q: I would like to purchase masks for health care workers during the COVID-19 Pandemic. How can I get them?
A: The FDA does not have a list of mask suppliers. If you are a health care facility, check with your supplier, distributor, or your local health department.
Q: I would like to reuse masks during the COVID-19 pandemic. What do I need to do?
A: In this period of high demand for masks, there are conservation strategy to mitigate shortages of masks.
