ISO 11193 is the international standard specification for single-use medical examination gloves. It has two parts: ISO 11193-1 covers gloves made from rubber latex or rubber solution (natural rubber latex, nitrile rubber, polychloroprene, styrene-butadiene rubber, and thermoplastic elastomers), and ISO 11193-2 covers gloves made from poly(vinyl chloride), PVC. The current edition of Part 1 is ISO 11193-1:2020. When a glove carries ISO 11193 compliance, it means the lot has been tested for freedom from holes, dimensions, physical properties (force at break and elongation), and biocompatibility.

1. Scope and Structure

ISO 11193-1:2020 (third edition, published August 2020) specifies requirements for packaged sterile or bulk non-sterile rubber gloves used in medical examinations and diagnostic or therapeutic procedures, and for handling contaminated medical materials. Gloves are classified by type and finish:

• Type 1: gloves made primarily from natural rubber latex
• Type 2: gloves made primarily from nitrile rubber latex, polychloroprene rubber latex, styrene-butadiene rubber solution or emulsion, or thermoplastic elastomer solution
• Finishes: textured, smooth, powdered, or powder-free surface

2. Key Test Requirements

ISO 11193-1 sets requirements across five areas, with test methods drawn from other standards:

Note: values above reflect typical published conformance data from major manufacturers; always verify the exact figures in the supplier batch test report. AQL stands for Acceptable Quality Limit - for medical examination gloves the hole tolerance is AQL 1.5 (maximum 1.5% of a sampled lot may leak).

3. How ISO 11193 Compares with EN 455 and ASTM D6319

Buyers often see ISO 11193, EN 455, and ASTM D6319 on the same datasheet. They test similar properties but express them differently:

The key insight: EN 455-2 and ISO 11193 express strength as force at break in Newtons, while ASTM D6319 expresses it as tensile strength in MPa. Both are valid; they measure different quantities (absolute force vs force per unit cross-section).

4. Where ISO 11193 Is Used

• GCC / Middle East: GSO has adopted ISO 11193-1 as GSO ISO 11193-1:2020, making it a common acceptance standard in Saudi Arabia, the UAE, and other Gulf states
• Southeast Asia, Latin America, and Africa: widely referenced in public hospital procurement
• Global manufacturers: most export factories certify to ISO 11193-1 plus EN 455 and/or ASTM D6319 for dual-market coverage
• China: the national standard GB 10213 is technically identical to ISO 11193-1

5. Buyer Checklist for ISO 11193 Compliance

1. Confirm the edition: request the exact standard and edition (e.g., ISO 11193-1:2020) named on the certificate and test report
2. Check the AQL: verify the water-leak AQL is 1.5 for medical examination use
3. Request full physical property data: force at break and elongation before AND after aging
4. Verify biocompatibility: ISO 10993 test reports (cytotoxicity, sensitization, irritation)
5. Review labeling: packaging symbols per ISO 15223, date of manufacture, batch code
6. Confirm finish: powder-free vs powdered and the powder residue test, if applicable
7. Cross-check with market rules: GSO ISO 11193-1 for GCC, EN 455 for EU, ASTM D6319 + FDA 510(k) for US

Data sources: ISO 11193-1:2020 (ISO.org); ISO 11193-2; GSO ISO 11193-1:2020; EN 455-1/2 series; ASTM D6319-19; ISO 2859-1; ISO 37; ISO 188; ISO 10993 series. Values cross-checked against published manufacturer conformance data. Information current as of August 2026.

FAQ

Q: Is ISO 11193 the same as EN 455 or ASTM D6319?

A: No, but they cover similar ground. ISO 11193 is the international standard for single-use examination gloves; EN 455 is the EU harmonized standard (Part 1 holes, Part 2 physical properties, Part 3 biological evaluation, Part 4 shelf life); ASTM D6319 is the US standard for nitrile examination gloves linked to FDA 510(k) clearance. Many export gloves are certified to two or three of these. Key differences: EN 455-2 and ISO 11193-1 report strength as force at break in Newtons, while ASTM D6319 reports tensile strength in MPa.

Q: Does ISO 11193 apply to PVC (vinyl) gloves?

A: Yes. ISO 11193-2 is the part that specifies requirements for single-use examination gloves made from poly(vinyl chloride). Part 1 covers rubber materials (natural rubber latex, nitrile rubber, polychloroprene, SBR, TPE). When a datasheet simply says ISO 11193, check which part is referenced - Part 1 for rubber, Part 2 for PVC.

Q: What AQL does ISO 11193 require for pinholes?

A: ISO 11193-1 requires an Acceptable Quality Limit of 1.5 for freedom from holes when tested with the water leak test and sampled per ISO 2859-1. This means no more than 1.5% of the sampled lot may leak. AQL 1.5 is the same threshold used by EN 455-1 and ASTM D6319 for medical examination gloves.

Q: How should a buyer verify ISO 11193 compliance?

A: Ask the supplier for the certificate and, more importantly, the batch test report showing the standard and edition, the batch code, the water-leak AQL result, force at break and elongation before and after aging, powder residue (if powder-free), and ISO 10993 biocompatibility data. The report must cover the specific batch being shipped, not a historical sample. You can also verify that the test laboratory is accredited (e.g., ISO/IEC 17025).

Q: Can a glove be certified to ISO 11193 and EN 455 at the same time?

A: Yes, this is common practice. Export factories typically certify a single product to ISO 11193-1 (international/GCC), EN 455 (EU), and ASTM D6319 (US) so the same glove can be sold across markets. Because the test methods for holes and aging are harmonized, dual certification usually requires little extra testing beyond the physical property differences (force at break vs tensile strength).