Vetted Domestic PPE Manufacturers

Supply chain teams across the U.S. continue to face supply shortages. One of the lessons learned during COVID-19 was the need to diversify and shorten the end-to-end supply chain.

To help hospitals and health care systems find reputable alternative sources, AHRMM is collaborating with GHX to vet U.S.-based personal protective equipment (PPE) manufacturers using the same tools, expertise and processes leveraged by its Vendormate solutions. The Vendormate process has been in place for more than 15 years and is a trusted source of information to credential new vendors. We will continue to identify and vet U.S. PPE manufacturers in an effort to create a comprehensive repository for the health care field. 


A&Z Pharmaceutical Inc.

•    Privately owned corporation - Emma Li Xu (Chairwoman & CEO)
•    Established in 1995 and located in Hauppauge, NY
•    2 manufacturing facilities on Long Island with 150 employees 
•    Manufacturer of D-Cal https://d-calusa.com/
•    Manufacturer of N95 Respirator at one of our facility on Long Island 

More Information:

Website: azpharmaceutical.com   

Email: jlarose@azpharmaceutical.com


ACI

ACI was founded in 2004 and is located in Lakeland, Florida. We are a medical device packager and manufacturer, working within the healthcare, consumer products, and nonwoven industry segments, in addition to producing FDA/NIOSH approved Surgical N95 Respirators. Our manufacturing and packaging solutions are for Class 1, Class II, and Class III medical devices including both sterile and non-sterile products. 

More Information:

Website: acipak.com   

Email: kpulcini@acipak.com


Aegle

Aegle was founded by a team of social impact investors in response to catastrophic shortages of PPE caused by the global COVID-19 pandemic. Our products are manufactured in a HUB/Opportunity Zone in Houston, Texas, and we are committed to bringing manufacturing jobs back to American soil, alleviating dependencies on foreign companies to protect the health and safety of the American people and creating innovative solutions for protecting consumer health.

More Information:

Website: aegleco.com   

Email: andy@aegleco.com


Altor Safety

Altor Safety is a locally owned manufacturer of surgical masks based here in New York State. Upon the outbreak of Covid and with the help of funding from New York State ESD retooling grant we were able to bolster our production of surgical face masks and bring more manufacturing jobs to New York. With our continued growth trajectory, we have been able to support the local community through mask donations, hiring locals from the community, and supporting local charities. We were also part of the enactment of the Medical Supplies Act into law which mandates NYS departments to purchase USA made PPE over $50,000. 

All raw material we used is locally sourced here in the USA and where possible materials are purchased from companies in New York State. We have the facility and ability to ramp up to meet demand even in times of pressure – we are local strong! 

Our commitment to buy raw materials in the USA and manufacturer a truly USA made product is underpinned by the long-term contracts we have with our suppliers. We also commit to always having at least 3 months stock of raw material on site in the event our suppliers are unable to fulfill their contractual obligations. Altor is committed to reshoring of these important Personal Protective Products which include the following: 

  • ASTM Level 1 Surgical Masks 3Ply 
  • ASTM Level 2 Surgical Masks 3Ply 
  • ASTM Level 3 Surgical Masks 4Ply 
  • No Nose Wire Surgical Masks 
  • KN95 Respirators / N95 Respirators 

During the COVID crisis, we have supplied over 100MM Masks to private industry, state/local government, military services, federal government agencies and more. Our corporate plan includes manufacturing additional critical protection items locally, creating even more jobs in the near future.

More Information:

Website: altorsafety.com     

Email: lee.mornan@altorsafety.com


BNX Converting

Website: bnx.com   

Email: adam.ravat@bnx.com


Dentec Safety

Dentec Safety Specialists is a family run business with 50 employees and over 40 years’ experience in the Safety Industry and Distribution with two facilities located in Lenexa, Kansas. One facility is dedicated to Manufacturing and the other to packaging, warehousing and distribution for respiratory and face protection products. 

Type of Products: NIOSH approved Reusable Elastomeric Half Mask Respirators With or Without Exhalation Valve, Replaceable N95 or P100 Filters, Disposable N95, Disinfecting Respirator Wipes, Respirator Fit Test Kits, and Accessories. ANSI Rated Face Shields, Goggles, Safety Glasses, and Portable Eyewash Stations.

More Information:

Website: dentecsafety.com   

Email: vinny@dentecsafety.com


Louis M. Gerson Co. Inc.

In business since 1956, the LOUIS M. GERSON CO., INC. has been producing NIOSH-approved, FDA-cleared N95-type respirators in its facility in Middleboro, Massachusetts since 1985.  The Gerson Company is vertically integrated and produces its own melt-blown filter material used in the production of these respirators. The company occupies a 70,000 SF factory on 25 acres. All respirators are produced in Middleboro on high-speed, automated equipment that Gerson has designed and developed. 
 
The Gerson Company has grown and thrived by offering world-class respiratory products ranging from disposable masks through half-mask and full-face cartridge respirators. Gerson prides itself on its commitment to producing the highest quality products at favorable, value-based pricing.

More Information:

Website: gersonco.com   

Email: sgerson@gersonco.com


Luosh USA

More Information:

Website: luoshusa.com

Email: Jeremy@Luoshusa.com


Lutema USA

Lutema USA, an MI Technologies, Inc. company, is based in San Diego, CA. Prior to the pandemic, MI Technologies, Inc. manufactured lighting components for Philips Lighting and distributed retail parts and components online. With over 20 years of logistics and manufacturing experience, and hundreds of employees globally, Lutema USA has grown to become a leader in manufacturing consumer PPE in the United States. Since April 2020 Lutema USA has manufactured PE gloves, ASTM Level 3 earloop style three and four layer masks, and 99% BFE/PFE five layer bi-fold and tri-fold respirators under our product brand M95i and M95Fi for adults, and M95c and M95Fc for kids and young adults, and M94k a four-layer respirator for toddlers. All masks and respirators are FDA listed, and are manufactured in an ISO 9001:2015/ISO 13495 standards environment in an FDA registered facility.

More Information:

Website: lutema.com   

Email: eddie@lutema.com


Premium-PPE

Premium-PPE proudly manufactures adult and pediatric disposable Surgical and Procedure masks. Our face masks, available in ASTM levels 1, 2, and 3, have received FDA 510(k) clearance, and are produced in Virginia Beach, Virginia. 

We have successfully supplied over 100 Million masks to the US Government via the Strategic National Stockpile and the Department of Homeland Security, as well as VA hospitals and many healthcare systems across the country. We consistently hold safety stock on all of our products to increase your supply chain resiliency and are happy to work with you directly for specific increased stocking requirements to maximize your supply chain security while minimizing your holding costs. 

We have an excellent supplier track record across all customer sectors in both quality and on time deliveries that has been well-established in our thirteen years of operations. Amongst the wide variety of industries that comprise our customer base, we have extensive experience working with healthcare organizations, hospital groups, doctors’ offices, dental practices, and assisted living facilities, as well as government contracts.

More Information:

Website: premium-ppe.com/   

Email: Brent@premium-ppe.com


Shawmut Corporation 

Founded in 1916, Shawmut Corporation is a fourth-generation, family-owned-and-operated advanced materials manufacturer, headquartered in West Bridgewater, MA, with 14 locations across the world. 

Shawmut is a global leader today in advanced materials, textile manufacturing, and lamination process innovation across the automotive, medical, military, protective, and custom lamination solutions markets, and is the largest independent laminator in the U.S. for technical fabrics. 
What started in the structure of America’s oldest woolen mill producing braided fabric and synthetic yarn has transitioned over time to create a range of composite materials, technical textiles, and lamination solutions across the globe. 

Shawmut Corporation also has a storied history of supporting the nation during times of crisis and need. The company made protective materials for the troops during World War I, bomb parachutes, field jackets and blankets during World War II, long underwear for soldiers during the Korean War, and now is manufacturing PPE to support the country through the COVID-19 pandemic and beyond. 

What remains constant at Shawmut is a commitment to process innovation, textile engineering expertise, and a dedication to being a trusted supplier to its customers. 
Shawmut Corporation applies its keen understanding of barrier and filtration fabrics and processing to its Protex™ line of personal protective equipment (PPE), including NIOSH-approved N95 respirator masks and AAMI-level PPE gowns, manufactured in the United States. 

More Information:

Website: shawmutcorporation.com   

Email: jprzepiorka@shawmutcorporation.com


If you are a domestic manufacturer who is interested in being evaluated for this list or you have a recommendation for a manufacturer you believe should be on this list, please contact us at ahrmm@aha.org.

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