SafeSource Direct, LLC announced today that its American-made personal protective equipment (PPE) met all the ISO 13485 and ISO 9001 certification requirements. 

“These ISO certifications reflect our commitment to quality,” said Justin Hollingsworth, CEO, SafeSource Direct. “Given our partnership with one of the nation’s leading health systems and the fact that we’re manufacturing in America, our customers can rest assured that our PPE meets the most stringent standards to keep people safe.”

The ISO (International Organization for Standardization) is an independent, non-governmental international organization with a membership of 168 national standards bodies. It develops and publishes global quality standards for a wide range of industries, from manufacturing to healthcare. 

“Safety and quality are non-negotiable in the medical devices industry, that’s why we developed ISO 13485,” says the ISO website about this standard that sets out the requirements for a quality management system specific to the medical devices industry. 

The organization states ISO 9001 demonstrates a company’s “ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements,” among other requirements. 

SafeSource Direct was launched in 2021 to meet America's demand for high-quality, domestically manufactured PPE. The COVID-19 pandemic exposed weaknesses in global supply chains and the dangers of substandard PPE. The United States learned the hard way that a trusted, reliable source for high-quality PPE was needed. 

In addition to being completely American owned and operated, SafeSource Direct stands out through its partnership with the Gulf South’s largest health system, Ochsner Health. It is the only PPE manufacturer that is U.S. provider-owned with U.S. provider-owned quality control.

Today, in its state-of-the-art facilities in Broussard, Louisiana, SafeSource Direct manufactures chemo-rated nitrile gloves, Level 1 and 3 surgical ear loop and surgical tie masks, and standard three-ply procedure masks – all with FDA 510(k) clearance. It also makes shoe covers and will soon be making N95 respirators, hair bouffant head covers, and isolation gowns.

SafeSource Direct earned ISO 13485:2016 certification for its surgical and procedure masks, cup respirators, shoe covers, gowns, and other surgical apparel; and it earned ISO 9001:2015 certification for its nonwoven materials, finished nonwoven products, and medical devices.

About SafeSource Direct

SafeSource Direct LLC is an American manufacturer of personal protective equipment (PPE) dedicated to keeping our nation’s healthcare and other essential workers safe on the job. At SafeSource Direct, success minded team-members use innovation and automation to provide high-quality American-made PPE at prices competitive with those of foreign suppliers. Headquartered in Lafayette Parish, La., SafeSource Direct operates a state-of-the-art manufacturing plant in Broussard as well as in neighboring St. Martin Parish. Positioned near the Mississippi River, rail lines, and interstate highways, it is well positioned to distribute PPE to the nation. To learn more about how SafeSource Direct is laying the groundwork for sustainability in the healthcare industry, visit SafeSourceDirect.com.