How Do Class 1000 Nitrile Gloves Achieve the Standard?

The Class 1000 standard is met through comprehensive contamination control, ensuring gloves contain very low levels of particles and ions throughout production, testing, and packaging.

1. Clean Production Environment

• Manufactured in cleanrooms (ISO 14644-1 Class 5–4), with HEPA filtration and laminar airflow.
• Environmental conditions are strictly managed: ≤10,000 particles ≥0.5μm/m³, 20–24°C, and 40–60% humidity to minimize particle adhesion.

2. Raw Material & Process Control

• High-purity nitrile latex (≥99.5%) is used, with low-migration additives to avoid ion or particle leaching.
• Gloves undergo 6–8 rinses with ultra-pure water (18 MΩ·cm) to remove residues.
• Some processes incorporate plasma treatment or dust-free drying to reduce contamination further.

3. Rigorous Testing & Certification

• Factory inspection checks:

  • Particles: ≤3,500 particles ≥0.5μm/glove, 0 particles ≥5μm.
  • Ions: ≤10μg/dm² for sodium, potassium, etc.
  • Plus tensile strength and sterility (for sterile gloves).
  • Third-party labs (CNAS/CMA accredited) verify compliance with IEST-RP-CC005.3 and GB/T 32170.

4. Clean Packaging & Storage

• Packaged in low-particle PE bags inside cleanrooms, vacuum-sealed or nitrogen-filled.
• Stored below 25°C, ≤60% RH, away from sunlight, heat, and solvents to prevent aging and contamination.

Conclusion

Class 1000 nitrile gloves achieve their standard through a full-chain approach:

• Preventing external contamination (cleanrooms)
• Reducing internal contamination (materials & processes)
• Verifying compliance (testing & certification)
• Avoiding secondary contamination (packaging & storage)

This integrated system—not a single step—ensures the gloves consistently meet Class 1000 cleanliness requirements.