Engineered for maximum microbial load reduction, fluid protection, and ergonomic hospital workflow compliance.
High-barrier SMMS non-woven construction with ultrasonic sealed critical zones, providing fluid and viral penetration resistance for high-bleed Spanish surgical cases.
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Ethylene Oxide validated sterile gown featuring breathable SMS fabric, soft knit cuffs, and full back wrap-around protection for operating room safety.
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Low-linting medical textile engineered for patient drapes and equipment wrapping, featuring high burst strength and fluid repelling barrier coating.
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Lightweight, ergonomic isolation and surgical gown designed for outpatient surgery centers, clinical examinations, and daily hospital hygiene protocols.
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Zoned poly-reinforced chest and sleeve panels providing impermeable barrier protection during orthopaedic, trauma, and urological interventions.
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Laminated fluid-proof barrier coat equipped with press-stud fasteners and elasticated wrists, engineered for hospital cleanrooms and laboratory staff.
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Premium 45gsm SMS non-woven gown with adjustable neck closure, offering high breathability paired with optimal fluid splash defense.
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State-of-the-art seam-welded sterile surgeon gown designed to eliminate pinhole fluid leakage in demanding surgical operating environments.
Send an InquiryA technical assessment of pre-operative surgical hand scrubbing dynamics, mechanical desquamation, and active antiseptic release under European Standard EN 12791.
Surgical Site Infections (SSIs) represent one of the most significant complications in modern perioperative care across the European Union, accounting for substantial patient morbidity, extended hospital stays, and elevated healthcare expenditure. In Spain’s healthcare network—encompassing both the public Sistema Nacional de Salud (SNS) and private hospital consortia (such as Quirónsalud, Vithas, and HM Hospitales)—the rigorous implementation of standardized pre-operative hand antisepsis remains the frontline defense against healthcare-associated infections (HAIs).
As a specialized global manufacturer and OEM/ODM exporter of medical-grade surgical disposables, our sterile surgical scrub brushes are specifically engineered to satisfy the demanding clinical standards set by the Spanish Agency of Medicines and Medical Devices (AEMPS) and European Medical Device Regulation (EU MDR 2017/745). Pre-operative skin scrubbing requires a delicate balance: achieving maximal reduction of both transient and resident skin microbiota while preserving skin integrity to prevent micro-fissures that can harbor opportunistic pathogens.
Clinical Information Gain: Mechanical friction provided by medical-grade polyethylene bristles facilitates the physical detachment of keratinized epidermal flakes harboring bacteria, while the integrated polyurethane sponge delivers a metered, slow-release dose of 4% Chlorhexidine Gluconate (CHG) or 7.5% Povidone-Iodine (PVP-I) without causing epidermal trauma.
Our OEM/ODM surgical scrub brush assemblies are manufactured in ISO Class 8 (100,000 class) controlled cleanroom environments, ensuring negligible initial bioburden prior to Ethylene Oxide (EO) or Gamma Irradiation sterilization. The structural anatomy comprises three key high-performance components:
To assist Spanish hospital procurement committees, infection control boards, and medical device distributors in selecting the appropriate scrubbing modalities, the following technical matrix details our three standard OEM/ODM configurations:
| Scrub Brush Variant | Active Ingredient & Dose | Antimicrobial Spectrum | Mechanism of Action | Primary Clinical Application |
|---|---|---|---|---|
| CHG 4% Medicated Brush | 4% Chlorhexidine Gluconate w/v (20ml equivalent dose) | Broad spectrum Gram-positive, Gram-negative, persistent residual activity up to 6 hours | Cell membrane disruption & cytoplasmic precipitation | Orthopaedic, cardiac, & implant surgeries requiring extended residual barrier protection. |
| PVP-I 7.5% Medicated Brush | 7.5% Available Povidone-Iodine w/v (20ml equivalent dose) | Bactericidal, virucidal, fungicidal, and sporicidal activity | Iodine oxidation of bacterial proteins & nucleic acids | General surgery, trauma, emergency procedures, & patients with known CHG sensitivities. |
| Dry / Plain Non-Medicated Brush | Nil (Impregnated or Dry Sponge option) | Mechanical removal of transient flora; compatible with hospital custom antiseptic solutions | Physical desquamation & surfactant cleansing | Flexible OR usage where facility-specific bulk antiseptics (e.g., alcohol-based rubs) are preferred. |
Customized OEM/ODM surgical consumable solutions aligned with regional SNS procurement frameworks.
In high-volume tertiary hospitals such as Hospital La Paz and Hospital 12 de Octubre, our AAMI Level 4 gowns and CHG 4% scrub brushes support complex organ transplantation and neurosurgical procedures demanding non-negotiable sterile continuity.
Serving healthcare networks like Hospital Clínic de Barcelona, our OEM private-label custom procedure packs and low-linting scrub brushes conform to strict regional environmental and micro-particle contamination standards.
Delivering cost-optimized, bulk-packaged dry and medicated surgical scrub brushes to large regional hospital networks across Seville, Granada, and Málaga under rigid public tender price-per-unit constraints.
How our contract manufacturing facilities guarantee uninterrupted supply chain readiness for European importers.
The regulatory landscape for medical devices in the European Union has undergone a fundamental transformation with the full implementation of the Medical Device Regulation (EU MDR 2017/745). Importers and distributors in Spain must ensure that all sterile Class I (sterile condition) and Class IIa surgical disposables are supported by complete Technical Files, verified Notified Body oversight, and valid CE Declarations of Conformity.
Unmatched quality assurance, in-house analytical testing, and customizable branding options for Spanish medical distributors.
Full international certification covering design, cleanroom molding, antiseptic formulation blending, EO sterilization, and final packaging release control.
Custom blister film printing, artwork localization in Spanish, hospital box branding, inner peel-pack customization, and UDI barcoding tailored to your brand.
Every lot undergoes rigorous internal quality checks: bristle pull-out force testing, antiseptic concentration assay, seal integrity burst testing, and bioburden evaluation.
Essential answers regarding regulatory registration, OEM minimum order quantities, and technical specifications.
Yes. Our surgical scrub brushes and medical disposables are manufactured under an ISO 13485:2016 quality management system and hold valid CE certification under EU MDR 2017/745. We provide Spanish distributors with complete technical dossiers, declarations of conformity, and test reports necessary for seamless registration with AEMPS (Agencia Española de Medicamentos y Productos Sanitarios).
Absolutely. We specialize in complete OEM and private-label programs for European distributors and group purchasing organizations (GPOs). This includes full artwork adaptation, primary peel-open blister printing in Spanish (Instrucciones de uso en español), custom dispenser box design, and GS1-compliant UDI barcode integration.
Our 4% Chlorhexidine Gluconate (CHG) scrub brush provides rapid bactericidal action with exceptional residual antimicrobial activity (binding to skin stratum corneum for up to 6 hours), ideal for orthopaedic and implant procedures. The 7.5% Povidone-Iodine (PVP-I) formulation offers broad-spectrum activity including bactericidal, virucidal, and sporicidal coverage, making it suitable for general surgery and patients with chlorhexidine allergies.
Our sterile scrub brushes undergo validated Ethylene Oxide (EO) sterilization (ISO 11135 compliant) or Gamma Irradiation, achieving a Sterility Assurance Level (SAL) of 10^-6. Each sterile unit is packaged in a high-barrier medical peel-pouch offering a validated 3-year or 5-year shelf life from the date of manufacture.
For standard stock formulations and plain dry brushes, our flexible MOQs start at 5,000 units. For full OEM custom branding and private label packaging, standard MOQs range from 10,000 to 20,000 units per variant. Shipments to main Spanish sea ports (Valencia, Barcelona, Algeciras) or air cargo to Madrid-Barajas typically take 2 to 4 weeks following order finalization.
Contact our medical device regulatory specialists today to request technical samples, CE documentation files, and factory-direct pricing for Spanish distribution.