In short: ASTM D3578 is the US standard for rubber examination gloves, EN 455 is the EU series for medical gloves, and ISO 11193 is the international standard for single-use rubber examination gloves. They measure largely the same properties, but each applies to a different market — your destination’s regulator dictates which standard your certificates must reference.

Examination gloves are judged against three main standards, and each one applies to a different market. Knowing which standard your market requires will help you choose a compliant product. Here is how EN 455, ASTM D3578 and ISO 11193 compare.

EN 455 — Europe

EN 455 is the European standard for medical examination gloves. It covers freedom from holes (Part 1), physical properties (Part 2) and biological evaluation (Part 3). A CE mark under the medical device or PPE regulation is the route to market for Europe.

ASTM D3578 — United States

ASTM D3578 is the US standard for rubber examination gloves. It sets limits on defects (AQL), physical properties and dimensions. Gloves for the US market are typically tested to this standard and registered with the FDA where required.

ISO 11193 — International

ISO 11193 is the international standard for single-use examination gloves. Many markets without their own national standard reference ISO 11193, and it is commonly cited alongside regional requirements.

What the Standards Have in Common

All three set limits on pinholes (AQL), dimensions, tensile strength and elongation. The practical difference is which market accepts which standard: EN 455 for Europe, ASTM D3578 for the US, and ISO 11193 for international buyers.

Certification at Pacific Resource Global

Pacific Resource Global, a Biomax Rubber Industries company, manufactures latex and nitrile examination gloves in Malaysia under ISO 9001 and ISO 13485:2016, with CE certification to EU PPE 2016/425 Category III, tested to EN ISO 374-1:2016 Type B and EN ISO 374-4:2019. Production is held to AQL 1.5.

What to Ask Your Supplier

  • Which standard is the product tested to: EN 455, ASTM D3578 or ISO 11193?
  • Can you provide the test report and Declaration of Conformity?
  • Does the certificate match the manufacturing name on the documents?

Request Standards Documentation

Contact [email protected] for test reports, certificates and a Declaration of Conformity for your market.

Sources and standards

The requirements referenced in this article come from the following public standards and regulations:

Pacific Resource Global manufactures the full examination glove range in Malaysia under an ISO 13485:2016 certified quality management system. To discuss specifications for your market, request pricing and samples.