Glove Intelligent Assistant
10.31.2025
At SW Sustainability Solutions, delivering the highest quality gloves while maintaining safety and sustainability is at the core of what we do. One of the ways we demonstrate this commitment is through our adherence to internationally recognized ISO standards. But what exactly are ISO certifications, and why do they matter?
ISO (International Organization for Standardization) certifications are globally recognized benchmarks that define quality, safety, and environmental management standards for businesses and their products.
Achieving ISO certification demonstrates that a company not only meets but continuously maintains rigorous standards in its operations, products, and processes.
Here’s a closer look at the certifications SW Sustainability Solutions holds:
ISO 9001 is the world’s most recognized standard for quality management systems. It ensures that quality measures are tracked, reviewed, and continuously improved across all operations.
At SW, our facilities adhere to ISO 9001 standards and go a step further by implementing additional internal measures. This ensures that every glove we produce meets consistent quality standards, supports employee safety, and delivers the highest customer satisfaction.
ISO 13485 sets stringent international requirements specifically for medical devices. Beyond ISO 9001, this standard includes additional regulatory requirements to meet the rigorous demands of medical-grade products.
All SW single-use gloves are manufactured to comply with ISO 13485 standards, guaranteeing exam-grade performance. This means that whether used in healthcare, laboratories, or other sensitive applications, our gloves meet the strict quality and safety standards required for medical use.
In a major move toward global harmonization, the U.S. FDA announced the transition from 21 CFR Part 820 (Quality System Regulation) to the Quality Management System Regulation (QMSR), which aligns with ISO 13485:2016.
This transition will take effect in February 2026, marking a significant shift in how medical device manufacturers demonstrate compliance in both U.S. and international markets.
For SW Sustainability Solutions, already certified to ISO 13485, this alignment strengthens our position as a globally compliant manufacturer. It reinforces that our quality systems meet the most current and internationally recognized medical device standards—ensuring our customers have complete confidence in the safety, consistency, and performance of every glove we produce.1
ISO 14001 certification verifies that a company complies with global environmental protection standards and regulations. It covers everything from sourcing raw materials to manufacturing processes and post-use disposal.
SW Sustainability Solutions has been an early adopter of ISO 14001. We continue to invest in industry-leading technologies to ensure our gloves are produced sustainably, helping customers reduce their environmental footprint while maintaining top performance and safety standards.
By adhering to these ISO standards, SW Sustainability Solutions ensures:
These certifications reflect our ongoing commitment to delivering innovative, high-quality, and sustainable hand protection solutions for every industry—today and in the future.
At SW, we are committed to leading the glove industry in environmental, social, and governance (ESG) practices. Our innovative EcoTek® technology exemplifies our dedication to sustainable solutions, while our expertise in sweat management ensures comfort and performance. We also offer specialized chemical compatibility support, assisting customers in selecting gloves tailored to their unique needs. Our mission is to provide products that prioritize safety, health, and environmental responsibility for our customers and the planet
Reference:
1 My ISO Consultants. (n.d.). FDA’s transition from CFR 21 to ISO 13485: What it means for medical device manufacturers. Retrieved from https://www.myisoconsultants.com/post/fda-s-transition-from-cfr-21-to-iso-13485-what-it-means-for-medical-device-manufacturers-my-iso-c