Quality Assurance & Global Compliance
Our surgical gloves are manufactured under internationally recognized quality management systems and comply with global medical device requirements, ensuring consistent quality, safety and reliability for healthcare partners worldwide.
FDA 510(k) Cleared
Our surgical gloves have obtained FDA 510(k) clearance, verifying product safety and performance in accordance with internationally recognized medical device requirements.
MDR CE Certified
Our surgical gloves comply with the European Medical Device Regulation (EU MDR), supporting distribution across European and international markets.
ISO 13485 Certified
Our manufacturing facilities operate under an ISO 13485 certified quality management system, ensuring strict control throughout raw material inspection, production, sterilization and final product release.
ISO 9001:2015
Our ISO 9001:2015 certified quality management system demonstrates our commitment to continuous improvement, process control and consistent product quality across our operations.
EN455 Compliance
Our sterile surgical gloves comply with EN455 requirements, including tests for freedom from holes, physical properties and biological evaluation to ensure product safety and reliability.
Free Sale Certificate
The Free Sale Certificate (FSC) verifies that our surgical gloves are legally manufactured and available for export from China, providing additional support for global healthcare distributors and importers.
Trusted by Global Healthcare Markets
From trusted distributors to healthcare suppliers worldwide, our surgical gloves support partners across diverse markets with reliable supply, consistent quality and professional OEM solutions. Backed by proven manufacturing capabilities and international certifications, we are committed to building long-term partnerships in the global healthcare industry.
- Global OEM Manufacturer
- FDA 510(k) Cleared
- EN455 Standard
- FSC Certified
- SATRA Tested
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