ISO 9001:2015
Quality management system certification covering the whole production and supply chain.
Our Certifications
The company is qualified with GMP, ISO9001, ISO13485, and HACCP quality management system certification, EU CE certification, and FDA registration.
FDA Registration
U.S. FDA registration for medical device establishment; examination gloves comply with FDA requirements.
CE (EU)
EU CE certification; medical-grade gloves conform to EN455, food-contact gloves to EN374.
Halal
Halal certification for food-grade glove production.
BSCI
Business Social Compliance Initiative audit — responsible manufacturing and labor standards.
HACCP
Hazard analysis and critical control points certification for food-safety management.
ISO 13485:2016
Medical device quality management system — the baseline for medical examination gloves.
GMP
Good Manufacturing Practice certification for pharmaceutical and health-food production.
Product Standards by Grade
| Grade | Standards | Notes |
|---|---|---|
| Medical Grade Gloves | ASTM D6319 & D6978 (US) · EN455 (EU) | Nitrile, latex, and vinyl examination gloves; complies with FDA & CE requirements. |
| Food Grade Gloves | GB4806.11-2016 (CN) · EN374 (EU) · NB27777 | Compliant with FDA & CE requirements; Halal certified. |
| Industrial Grade Gloves | Customizable | Fully customizable industrial disposable gloves — choose your thickness, color, and texture. |