At a glance: a serious latex glove supplier holds ISO 13485:2016, CE marking under EU PPE Regulation 2016/425 (Category III, assessed by a notified body), and chemical-protection testing to EN ISO 374-1 (Type B) and EN ISO 374-4. Always verify the certificate number against the EU NANDO database.
When you import latex examination gloves, the certificates your supplier holds determine whether the gloves can legally enter your market and whether they meet quality and safety expectations. Here is a clear breakdown of the certifications that matter, and how to verify them.
ISO 13485:2016 — Medical Device Quality Management
ISO 13485:2016 is the international quality management standard specific to medical devices. A supplier holding this certificate demonstrates that its design, production and traceability processes are independently audited. It is a baseline requirement for most serious medical glove buyers.
CE Marking Under EU PPE Regulation 2016/425
To be placed on the European market, examination gloves classified as personal protective equipment (Category III) must carry the CE mark. Category III covers products that protect against serious risks, and it requires assessment by an independent notified body — not just self-declaration.
EN ISO 374-1:2016 and EN ISO 374-4:2019 — Chemical Protection
EN ISO 374-1:2016 defines the requirements and test methods for gloves that protect against dangerous chemicals and microorganisms, including a classification of protection (our gloves are Type B). EN ISO 374-4:2019 covers resistance to degradation by chemicals.
ISO 9001 — General Quality Management
ISO 9001 is the broad quality management standard covering the whole organisation. While not medical-specific, it confirms consistent process control and is often required alongside ISO 13485.
Notified Body 2777 (SATRA) — The Audit Trail
Our CE type-examination certificate (No. 2777/26778-01/E00-00) was issued by SATRA Technology Centre, which is Notified Body 2777. You can trace this number to verify that the gloves have been independently tested and certified.
How to Verify a Supplier’s Certificates
- Ask for the certificate number, not just a logo.
- Check the notified body against the EU NANDO database.
- Request the Declaration of Conformity (DoC) and latest test reports.
- Confirm the certificate is in the manufacturer’s legal name (Biomax Rubber Industries Sdn Bhd).
Need Certified Latex Examination Gloves?
Contact [email protected] and we will send our CE, ISO 13485 and ISO 9001 certificates.
Sources and standards
The requirements referenced in this article come from the following public standards and regulations:
- ASTM D3578 – Standard Specification for Rubber Examination Gloves
- European Commission – Personal Protective Equipment Regulation (EU) 2016/425
- European Commission – Medical Devices Regulation (EU) 2017/745
Pacific Resource Global manufactures latex examination gloves made in Malaysia in Malaysia under an ISO 13485:2016 certified quality management system. To discuss specifications for your market, talk to our export team.