Compliance · 6 min · May 2026
What certification should a surgical glove exporter check for?
For examination and surgical gloves, check three things before you place an export order: the product standard the gloves are tested against (ASTM D6319 for nitrile examination gloves, ASTM D3578 for latex, EN 455 parts 1-4 in the EU), the manufacturer's quality management certification (ISO 13485 for medical devices, not ISO 9001 alone), and the destination-market registration (CE technical file with a Notified Body for sterile or Class I sterile gloves, FDA 510(k) for the US, CDSCO licence in India).
Why is ISO 9001 not enough on its own?
ISO 9001:2015 certifies that a company runs a documented quality management system. It says nothing about medical device risk management, biocompatibility files, sterilisation validation or post-market surveillance. ISO 13485:2016 adds those requirements specifically for medical device manufacturers.
If a supplier answers a certification question with an ISO 9001 certificate only, ask directly whether an ISO 13485 certificate exists for the same site and the same product scope. Scope matters: a certificate can cover the company while excluding the product line you are buying.
Which product standards apply to gloves?
Nitrile examination gloves are commonly tested against ASTM D6319; latex examination gloves against ASTM D3578; vinyl against ASTM D5250. In Europe, EN 455-1 covers freedom from holes (AQL), EN 455-2 physical properties, EN 455-3 biological evaluation and powder residue, EN 455-4 shelf life.
Ask for the test report, not just the standard name. A report should state the AQL used for pinhole testing (1.5 is typical for examination grade), tensile strength before and after ageing, and the batch it relates to.
What documents should accompany the shipment?
A commercial invoice and packing list, a certificate of analysis or batch test report, a declaration of conformity where CE marking applies, a free sale certificate for many import markets, and the manufacturing and expiry dates printed on the carton.
For sterile products, add the sterilisation batch record and the ETO residual test result. For a first order, request pre-shipment photographs of cartons and the master label.
How does Dzire Surgical India handle this?
Dzire Surgical India Pvt Ltd is a manufacturer and exporter of disposable surgical and medical consumables, established in 2014 in Surat, Gujarat, India. Certificate copies are shared directly with buyers on request as part of the RFQ process rather than published as badges on this site.
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