People use face masks everyday to provide protection against the risk of infection. But consumer demand for them spikes at various times, such as when news surfaces about the spread of coronavirus. However, it is important to note that not all masks are created equal. And some do not provide protection at all. It is possible for a generic manufacturer, such as a garment factory, to become a surgical mask manufacturer. But there are many challenges to overcome. It’s also not an overnight process, as products must be approved by multiple bodies and organizations. Hurdles include:
Navigating test and certification standards organizations:
A surgical mask manufacturer must know the web of test organizations and certification bodies as well as who can give them which services. Government agencies including the FDA, NIOSH, and OSHA set protection requirements for end users of products like masks. Then organizations such as the ISO and NFPA set performance requirements around these protection requirements. Then test method organizations such as ASTM, UL, or AATCC create standardized methods to ensure a product is safe. When a company wants to certify a product as safe, it submits its products to a certification body such as CE or UL.
Then, they tests the product itself or uses an accredited third party testing facility. Engineers evaluate the test results against performance specifications. If it passes, the organization puts its mark on the product to show it’s safe. Employees of certification bodies and manufacturers sit on the boards of standards organizations as well as end users of the products. A new surgical mask manufacturer must navigate the interrelated web of organizations. They handle its specific product to ensure the mask or respirator it creates is properly certified.
Navigating government processes:
The FDA must approve surgical masks, which under pre-pandemic circumstances could be a long process. Especially for a first-time company that hasn’t gone through the process before. However, the FDA has recently relaxed rules to allow some surgical mask manufacturers to get emergency use authorizations for surgical masks. It is also willing to work with manufacturers pivoting from other products.
Knowing the standards to which a product must be manufactured:
Surgical mask manufacturer need to know the testing that a product will go through. So they can make it with consistent results and ensure it’s safe for the end user. PPE customers can be difficult to attract since they tend to stick to proven products, especially when it could literally mean their lives are on the line.
Competition against large companies:
Surgical masks and respirators are highly specialized products that larger companies with experience in this area can manufacture more easily. Partly from this ease, larger surgical mask manufacturers can also make them more cheaply. Therefore, they can offer products at a lower price. Additionally, the polymers used in creating masks are often proprietary formulas.
Navigating foreign governments:
For surgical mask manufacturers wishing to sell to US buyers in the wake of the coronavirus pandemic, they have to navigate the laws and government bodies.
Getting supplies:
Currently, there are face mask material shortages, especially with melt-blown fabric. A single melt-blow machine can take months to make and install due to its need to consistently produce an extremely precise product. Because of this it has been difficult for melt-blown fabric manufacturers to scale up. And the massive global demand for face masks made from this fabric has created shortages and price hikes.
Now that we’ve outlined details on challenges to surgical mask manufacturers trying to break into the field. We hope this will enable you to source more effectively.
