International Standards for NBR Latex

1. ISO 11193‑1:2020 – Medical Examination Gloves

• Classifies Type 2 gloves primarily made from nitrile rubber latex (NBR).

• Specifies test methods: tensile strength, elongation post-ageing, freedom from holes, sampling (AQL 2.5%).

• Ensures biocompatibility through ISO 10993 series.

2. ISO 23464:2020 – Cleanroom Nitrile Gloves

• Defines specifications for ISO Class 4–6 gloves used in controlled environments like semiconductor or pharma plants.

3. ASTM Standards (U.S.)

• ASTM D6319 – Nitrile exam gloves for medical use.

• ASTM D412, D3767 – Core tests for rubber properties (tensile, dimension).

• ASTM D6978 – Permeation test for chemotherapy drugs.

• ASTM D5151, D6124 – Pinhole detection; powder residue measurement.

4. EN 455 Series (Europe)

• EN 455-1 through EN 455-4 cover barrier performance, physical tests, biological evaluation, and shelf-life – aligned with ISO 11193 standards but with stricter AQL values (1.5%).

5. ISO 1629 – Nomenclature for Rubber

• Defines classification codes: NBR (nitrile), NR (natural rubber), SBR, EPDM, etc. Ensuring consistent terminology.

Market Trends & Regulatory Drivers in China & Europe

• Rising demand for powdered‑free, biocompatible nitrile gloves in healthcare and cleanrooms.

• Stricter VOC and chemical regulations, especially for chemotherapy and food-grade applications, prompting compliance with ASTM D6978 and EN ISO 374-5.

• Cleanroom standards (ISO 23464) driving niche industrial demand in East Asia.

Summary Table

Implications for Producers and Buyers

• Ensures product safety, quality, and regulatory acceptance across key markets.

• Supports cleanroom and medical applications with strict sterility and barrier requirements.

• Upholds clear labeling and traceability through global nomenclature standards.

Bottom Line

Compliance with ISO 11193‑1, EN 455, ASTM specifications, and cleanroom standards like ISO 23464 is central to ensuring that nitrile latex products—from gloves to industrial coatings—meet global safety, performance, and regulatory expectations. It also helps manufacturers streamline global market access and maintain quality consistency.