About USA Nitrile Gloves

USA Nitrile Gloves: Advancing the vision of Made in America

USA Nitrile Gloves is a proud to be affiliated with globally recognized leaders in medical disposable PPE, exporting to over 165 countries.

Global Reach: Offices and distribution centers in the US, Canada, Brazil, Ireland, UK, Japan, Hong Kong, and Singapore.
Manufacturing Presence: 18 Manufacturing plants globally that include a US facility; medical face mask facility in Canada
Own Brands: Flagship brands include exclusive U.S. manufacturing.

Overseas Operations Established: 1987 (38 years experience)

US Operations Established: 2021

MHI Valued Proposition: Comprehensive glove portfolio, scalable, dedicated production lines to meet market demand, direct shipping, and warehousing in Houston and Chicago to support consistent, demand-driven supply and reduce risk through multiple shipping locations.

Production Capabilities

Cutting-Edge Manufacturing

Phase 1 Production Overview

~4.8 billion gloves annually upon Phase 1 completion
Four planned phases to reach over 19 billion gloves per year (19 million cases)

Advanced Manufacturing Technology

Highly automated, robotic production lines and packing stations
Artificial Intelligence visual inspection powered by NVIDIA technology, ensuring 99.99% accuracy in defect detection
Dual-High Speed Efficiency Dipping Lines

Strategic Product Focus

disposable nitrile gloves for healthcare, retail, industrial, MRO, automotive, janitorial and food service sectors

Innovation & Continuous Improvement

On-site R&D Center dedicated to advancing product features and optimizing production processes

World-Class Certifications

Certified to ISO 9001, ISO 13485, 21 CFR 820, and MDSAP (Medical Device Single Audit Program)

Commitment to Quality

American-Made Excellence

Complies with FDA Medical Device Regulation for Class 1 medical devices (21 CFR 880.6250) and general controls (21 U.S.C. 360c(a)(1)(A)).
Meets ASTM D6319 specifications for Freedom from Holes, Physical Dimensions Test, Physical Requirement Test, and Packaging.
Conforms to ASTM D5511 and D5526 standards for anaerobic biodegradation testing.
Follows ASTM D6978-05 for resistance to chemotherapy drug permeation and Fentanyl resistance in medical gloves.
Adheres to EEC regulations for materials in contact with food (Regulation EEC 1935/2004, EC 10/2011, and EC 2023/2006).
Compliant with FDA 21 CFR 177.2600 for food contact; ASTM D412, D471, and D6284.
Manufactured in compliance with ISO 9001:2015 and ISO 13485:2016 Quality Management Systems. 8/25 completion
NFPA 1999: Standard on Protective Clothing and Equipment for Emergency Medical Operations
AQL- Exceeding industry standard (1.5)