Can Any Manufacturer Become a Surgical Mask Manufacturer?


It is possible for a generic manufacturer, such as a garment factory, to become a 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 company 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, and 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, which then tests the product itself or uses an accredited third party testing facility. Engineers evaluate the test results against performance specifications, and if it passes, the organization puts its mark on the product to show it’s safe. All of these bodies are interrelated; employees of certification bodies and manufacturers sit on the boards of standards organizations as well as end users of the products. A new manufacturer must be able to navigate the interrelated web of organizations that handle its specific product to ensure the mask or respirator it creates is properly certified.

Navigating government processes. The FDA and NIOSH must approve surgical masks and respirators. Since these are government bodies, this can be a long process, especially for a first-time company that hasn’t gone through the process before. Additionally, if anything goes wrong during the government approval process, a company must start all over again. However, companies that already have had similar products go through the process can base their approach off previous approvals to save time and work.

Knowing the standards to which a product must be manufactured. Manufacturers 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. The worst case scenario for a safety product manufacturer is a recall because it destroys their reputation. 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. Over the past decade or so, smaller companies in this industry have been acquired and consolidated into larger companies like Honeywell. 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 companies can also make them more cheaply, and therefore offer products at a lower price. Additionally, the polymers used in creating masks are often proprietary formulas.

Navigating foreign governments. For manufacturers specifically wishing to sell to Chinese buyers in the wake of the 2019 coronavirus outbreak, or a similar situation, there are laws and government bodies that must be navigated.

Getting supplies. Currently there are 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 masks made from this fabric has created shortages and price hikes.

If you have any more questions regarding mask production cleanrooms, or if you’re looking to purchase a cleanroom for your business, contact Airwoods today! We’re your one-stop shop to getting the perfect solution. For additional information about our cleanroom capabilities or to discuss your cleanroom specifications with one of our experts, contact us or request a quote today.


Post time: Mar-30-2020

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