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PE Overshoes

PE Overshoes

PE Overshoes, Disposable PE Overshoes, PE Overshoes supp

Disposable N95 Face Mask

Disposable N95 Face Mask

Disposable KN95 Face Mask Material: Needle punched cotto

Disposable Medical Face Mask

Disposable Medical Face Mask

Disposable Medical Mask Material: NonWoven Fabric+Meltbl

Disposable KN95 Face Mask

Disposable KN95 Face Mask

Disposable N95 Mask Material: 5 ply Non-woven fabric Col

Infrared Forehead Thermometer

Infrared Forehead Thermometer

Infrared Forehead Thermometer Sample: Free Brand: Orient

Disposable Isolation Coveralls

Disposable Isolation Coveralls

General purpose, Cleanroom, Construction/building, Clean

Disposable Medical Gloves

Disposable Medical Gloves

Disposable Medical Gloves Material: PVC Color: Transpare

Can Any Manufacturer Become a Surgical Mask Manufacturer?

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:

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 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 companies to get emergency use authorizations for surgical masks. It is also willing to work with manufacturers pivoting from other products. More information as of April 2020 can be found here.

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.

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.
 

Related Products

Disposable Medical Face Mask

Disposable Medical Face Mask

Disposable Medical Mask Material: NonWoven Fabric+Meltblown N

Disposable KN95 Face Mask

Disposable KN95 Face Mask

Disposable N95 Mask Material: 5 ply Non-woven fabric Color: w

Disposable N95 Face Mask

Disposable N95 Face Mask

Disposable KN95 Face Mask Material: Needle punched cotton+Mel


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