Glove Intelligent Assistant
02.11.2026
As the ASK GIA blog has mentioned previously, accredited certifications are one of the ways end users and customers determine the trustworthiness of a brand. Usually this translates into cost effectiveness of a product. Having verified third party organizations certify a product should directly translate into the quality of a product. Longer lasting products equate to replacing less products, which leads to end users and businesses spending less in that area.
These are known widely as ISO standards within various industries. This week will touch upon ISO 13485. ISO 13485 is a quality management system companies are focused on quality control specific to manufacturing medical devices. At the core it emphasizes employee competency and their ability to maintain quality control infrastructures in place. It establishes guidelines on how to safely design, produce, and service medical devices. Exam grade gloves are classified under FDA 21 CFR 880.6250 as Class I medical devices and these device manufacturing fall under ISO 13485 quality system.
ISO 13485 requires strict documentation and record keeping for each step of the quality management system with specific assignment of each step to a specific employee. While this certification is necessary for production houses to even market their products on the market, it is also a very important identifier for customers.
It means that there is documentation of each step in the production process. Down to manpower, raw materials, and life cycles. Documentation allows for traceability and transparency. If there is any flaw in the product or servicing of the product, the production house can quickly identify and justify why it happened. ISO 13485 allows for quick corrective action as well. Leading to higher quality products and more consistency in the manufacturing process. It equates to the brand being able to consistently produce high quality products.
SW is dedicated to adhering to industry standards and we are in compliance with ISO 13485. Our production house uses scientifically verified and industry-approved principles to manufacture our products. SW gloves meet global safety and quality standards while also implementing sustainable materials and practices.
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