Medical-grade sterile disposable surgical gowns engineered for critical barrier protection, ergonomic mobility, and verified compliance with AAMI PB70 & EN 13795 standards.
Surgeine Healthcare manufactures premium sterile disposable surgical gowns engineered specifically for high-risk surgical environments, group purchasing organizations (GPOs), and medical device distributors across 25+ countries. Operating four state-of-the-art cleanroom manufacturing units in India, our production adheres strictly to ISO 13485:2016 quality management systems and EU MDR 2017/745 certification criteria.
Designed with medical-grade SMMMS, Spunlace, and Microporous laminate non-woven fabrics, Surgeine surgical gowns deliver verified liquid strike-through resistance, low-linting performance, and supreme tactile comfort during extended surgical interventions.
Full compliance with AAMI PB70 (Levels 2, 3, and 4) and EN 13795 standards, offering certified protection against liquid impact, pressure, and microbial cross-contamination.
Sonically sealed sleeve and shoulder seams eliminate needle-hole fluid strike-through, ensuring absolute barrier protection in critical exposure zones.
Advanced breathable fabric structures maintain body thermoregulation, reduce wearer fatigue, and minimize skin irritation during long surgical procedures.
Selecting the appropriate barrier performance level is essential for optimizing clinical safety and hospital procurement budgets. Surgeine gowns are classified according to standardized fluid exposure risk categories.
| Gown Classification | Barrier Level (AAMI PB70) | Fabric Technology | Fluid Resistance & Test Standard | Recommended Clinical Procedures |
|---|---|---|---|---|
| Bond Series | AAMI Level 2 / Level 3 | 5-Layer SMMMS Polypropylene | Hydrostatic Head > 30 cm H2O / Impact Penetration < 1.0g | General surgery, diagnostic procedures, endoscopy, suturing |
| Comforto Series | AAMI Level 3 | Woodpulp / Polyester Spunlace | Cloth-like feel, high fluid repellency, minimal lint generation | EENT, ophthalmic, day surgery, low-to-moderate fluid cases |
| Lyra Series | AAMI Level 3 (ARAS) | Alcohol Repellent & Anti-Static SMMMS | Resists low surface-tension fluids (blood, alcohol, saline) | General laparotomy, OB/GYN, urological procedures |
| Suko Series | AAMI Level 4 Reinforced | Poly-Reinforced SMMMS / Spunlace | Critical zone fluid impervious barrier, high burst strength | Orthopedic joint replacement, trauma, C-section, cardiovascular |
| Microcare Series | AAMI Level 4 Imperial | Microporous Film Laminate | ASTM F1670 Synthetic Blood & ASTM F1671 Viral Penetration Pass | High-irrigation cases, transplant surgery, infectious exposure risks |
Our core product lines serve diverse healthcare preferences, balancing barrier protection, drapeability, and cost-effectiveness for bulk procurement.
Constructed using advanced 5-layer SMMMS technology, Bond gowns combine outer liquid-repellent spunbond layers with inner meltblown filtration cores for outstanding bacterial barrier capability.
Engineered with premium Woodpulp/Polyester Spunlace fabric, Comforto gowns deliver a textile-like tactile softness, making them the preferred choice for surgical teams desiring natural breathability.
Lyra gowns feature Alcohol-Repellent and Anti-Static (ARAS) non-woven substrate, designed specifically to prevent fluid penetration from low surface-tension liquids used in modern operating rooms.
Designed for high-fluid, long-duration surgical operations where fluid strike-through poses significant health risks. Incorporates chest and sleeve impervious reinforcements or microporous laminate.
Surgeine Healthcare operates full vertically integrated manufacturing facilities. From raw non-woven material evaluation to automated cutting, ultrasonic sealing, ethylene oxide (EO) sterilization, and in-house laboratory testing, every step is controlled under ISO 13485:2016 management standards.
All surgical gown assembly and sterile packaging take place in certified Class 100,000 cleanrooms to eliminate environmental bioburden.
Internal laboratories perform routine Hydrostatic Head, Gelbo Flex Linting, Tensile Burst Strength, and Seam Integrity checks per batch.
Validated Ethylene Oxide (EO) sterilization processing complies with ISO 11135 standards, achieving a Sterility Assurance Level (SAL) of 10⁻⁶.
We empower international medical supply companies, group purchasing organizations, and brand owners to expand their market presence with complete contract manufacturing support.
Tailor gown dimensions, sleeve construction (raglan/set-in), tie placement, cuff materials, and critical zone reinforcement areas.
Available in individual medical pouch wrapping with wrap towels, inner book-folds, and integration into specialized procedure packs.
Complete CE MDR technical files, biocompatibility reports (ISO 10993), sterilization validation, and local health authority registration dossiers.
Surgeine surgical gowns are engineered and tested to comply with ANSI/AAMI PB70 Standards (Level 2, Level 3, and Level 4) as well as EN 13795 European requirements for surgical apparel. Testing covers fluid impact penetration, hydrostatic pressure resistance, and synthetic blood/viral penetration (ASTM F1670/F1671).
We utilize 5-layer SMMMS non-woven, alcohol-repellent & anti-static SMMMS (ARAS), woodpulp/polyester Spunlace fabric, and film-laminated microporous breathable non-woven materials to achieve a balance between microbial barrier protection and thermal breathability.
Yes. Surgeine Healthcare provides comprehensive OEM and private label manufacturing services for international distributors and hospital networks. Customizations include gown sizing, barrier zone reinforcement, custom wrapping, sterile pouch design, inner folded orientation, and multi-language packaging.
Every production lot includes Batch Certificates of Analysis (CoA), ISO 13485:2016 traceability, CE Declaration of Conformity under EU MDR 2017/745, EO Sterilization Validation documentation, and biocompatibility test reports.
Access technical data sheets, barrier classification charts, material sample request forms, and export container loading configurations for our entire surgical gown portfolio.
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