In the modern medical and industrial landscape, the term "CE Certified" is not merely a label; it is a rigorous testament to safety, health, and environmental protection. As a leading CE certified disposable gloves factory, Shanghai SwellMed Medical Co., Ltd. recognizes that the barrier between a clinician and a pathogen must be infallible. The CE mark signifies compliance with Regulation (EU) 2017/745 for medical devices and Regulation (EU) 2016/425 for personal protective equipment (PPE).
Our manufacturing process adheres to the EN 455 series (for medical use) and EN ISO 374 (for chemical and micro-organism protection). This ensures that every glove—whether Nitrile, Latex, or Vinyl—exhibits the required tensile strength, freedom from holes (AQL levels), and biocompatibility essential for high-stakes procedures.
The global healthcare market relies heavily on the resilience of the Chinese medical supply chain. Our factory in Shanghai serves as a critical hub, leveraging advanced automation and integrated logistics to provide "Information Gain" to our partners. Why does this matter?
In European surgical theaters, ultra-thin Nitrile gloves with textured fingertips are preferred for precision. Our factory provides specialized sizing and cuff lengths to meet localized clinical ergonomic standards.
In R&D environments across North America, chemical permeation rates (under EN 16523-1) are the primary intent. We provide detailed "Chem-Resistance Charts" to help lab managers select the right protection.
Compliance with "Food Grade" standards is essential for global exports. Our powder-free, latex-free options prevent allergen cross-contamination in large-scale food processing plants.
Shanghai SwellMed Medical Co., Ltd. is a globally recognized manufacturer of high-quality single-use sterile medical devices, with a strong focus on infection control and surgical safety. We support OEM & ODM customization for healthcare providers, distributors, and brand owners worldwide.
Our core strength lies in seamlessly integrating cutting-edge R&D with practical clinical application. We possess deep domain expertise and hold numerous patents for our innovative technologies. Our products, backed by robust clinical data, are designed with a user-centric approach, ensuring reliability, ease of use, and improved patient outcomes. Furthermore, our global compliance certifications (e.g., FDA, CE) and dedicated professional support team guarantee trust and partnership at every stage.
Our medical devices have demonstrated exceptional clinical value, supporting over 50,000 successful procedures worldwide. Sales have grown 200% in three years, driven by surgeon trust and proven results in enhancing surgical precision and reducing recovery times. This performance underscores our role as a key innovator in the medical field.
Navigating international regulations requires more than just a certificate. Our Localized Support model includes:
Regulatory Dossier Preparation: We provide the technical documentation (TF) required for your local health authority registrations.
Sterilization Validation: Comprehensive EO (Ethylene Oxide) or Gamma radiation validation reports are standard.
Market-Specific Labeling: Multi-language instructions and UDI (Unique Device Identification) implementation for EU MDR compliance.
SwellMed Medical
