Certificates are the first thing serious buyers request and the fastest way to disqualify a supplier. Here is what each standard actually covers, so you can ask for the right document for your market.
Quality system: ISO 13485
ISO 13485 certifies the factory quality management system for medical devices, not any individual product. It tells you the production process is controlled and traceable. Ask for it whenever you buy examination gloves, wound care or any product with a medical claim.
For the EU: CE, EN 455, EN 374
CE marking is the legal gateway to the EU market. For single-use medical gloves the supporting standard is EN 455; for chemical and micro-organism protection it is EN 374. A glove sold for both uses should be tested to both.
For the US: ASTM D6319, ASTM D6978, FDA
ASTM D6319 is the base standard for nitrile examination gloves. ASTM D6978 covers resistance to chemotherapy drugs, required for oncology settings. Food-contact gloves fall under FDA 21 CFR 177.2600.
Quality level: AQL
AQL 1.5 is the accepted quality limit for pinhole defects in examination gloves. A lower AQL means stricter inspection. Our glove lines run at AQL 1.5 as standard with 100 percent pre-shipment inspection.
Social compliance: BSCI
Large EU retailers and pharmacy chains increasingly require a BSCI audit before onboarding a supplier. If your buyer is a retailer, ask your manufacturer for their BSCI audit result early. It takes time to arrange if they do not have one.
Certificate copies and test reports for our product lines are available on request. Tell us your destination market and we will send the relevant set.