AAMI PB70 & EN 13795 Verified
Every lot of protective surgical apparel undergoes strict hydrostatic head and fluid strike-through testing in our internal laboratories.
Engineered for absolute perioperative safety. ISO 13485 & EU MDR certified protective gowns, drapes, and surgical attire manufactured in Class 100K/10K cleanrooms and trusted across 25+ global markets.
Customized component lists, fold sequences, barrier classifications (AAMI Levels 2–4), and multi-lingual packaging built for hospital procurement groups.
Complete single-use infection barrier systems engineered to reduce Surgical Site Infections (SSIs) while ensuring fluid resistance and thermal comfort.
Every lot of protective surgical apparel undergoes strict hydrostatic head and fluid strike-through testing in our internal laboratories.
Multi-layer SMS, SSMMS, and breathable micro-porous laminate materials providing ultra-low linting and superior tear resistance.
Uninterrupted CE certification maintained since 2008 and updated under EU MDR in 2024, facilitating immediate global tender participation.
For modern hospital procurement directors, clinical infection control committees, and global medical distributors, selecting the appropriate protective surgical apparel is a critical decision directly linked to surgical outcome quality, clinician occupational safety, and regulatory compliance.
Operating rooms are highly dynamic environments where surgical staff face continuous exposure to bloodborne pathogens, body fluids, irrigation liquids, and aerosolized infectious agents. Protective surgical apparel serves as the primary physical barrier preventing cross-contamination between the non-sterile environment and the surgical wound.
Since 2002, Surgeine Healthcare has operated as a vertically integrated manufacturer specializing in high-barrier surgical nonwovens. Operating across four state-of-the-art production facilities—including a dedicated 2023 expansion facility for custom procedure integration—we control the complete manufacturing value chain: from hotmelt substrate lamination and precision cleanroom conversion (Class 100K and Class 10K) to automated ethylene oxide (EtO) sterilization and package integrity validation (ISO 11607).
Tailored specifically for international procurement specifications, hospital tenders, and OEM distributors. Each product line undergoes rigorous barrier classification matching procedure-specific fluid stress.
Engineered with multi-layer SMS and breathable PE-laminate reinforcement. Features ultrasonic seam sealing, raglan sleeves, and adjustable hook-and-loop neck closures for total liquid strike-through prevention.
View Gown Specifications Staff & OR SafetyComprehensive OR personal protection, including fluid-resistant scrub suits, isolation coveralls, anti-static shoe covers, sterile bouffant caps, and high-clarity optical face shields designed for high-risk zones.
Explore Protective Apparel EN 13795 Fluid ControlFluid-collection pouches, integrated incise films, and absorbent reinforcement zones for orthopaedic, cardiac, neuro, and caesarean surgeries. Eliminates pool formation and maintains sterile zone boundary integrity.
Examine Drape Systems Workflow OptimizationStreamline OR setup times by up to 45%. Combines procedural protective apparel, specialized drapes, equipment covers, and disposable instruments pre-assembled for specific clinical protocols.
Configure Procedure Pack Pre-Op Skin AntisepsisPioneered in India: Single-use 2% Chlorhexidine Gluconate with 70% IPA applicators engineered for uniform, touch-free solution delivery to eliminate skin flora prior to surgical incision.
Discover CHG Solutions Infection ControlRapid-turnaround absorbent table sheets, armrest covers, and bio-hazard disposal bags designed to minimize between-case contamination risk and reduce theatre downtime.
Explore Turnaround KitsWhen evaluating protective surgical apparel, procurement managers must look beyond simple gsm weight. Surgeine Healthcare utilizes advanced polymer chemistry to balance protection, thermal dynamic regulation, and mechanical durability:
Composed of spunbond layers for high tensile strength and meltblown micro-fibrous layers that act as a tortuous path barrier against bacterial passage. Ideal for AAMI Level 2 and Level 3 surgical gowns and general theatre attire.
Breathable membrane laminates engineered with microscopic pores smaller than a water droplet but larger than water vapor molecules. Delivers 100% liquid imperviousness (AAMI Level 4 / ASTM F1671) while permitting heat evacuation.
Traditional sewn seams create thousands of needle punctures that allow liquid strike-through. Surgeine utilizes high-frequency ultrasonic bonding to fuse fabric edges, creating leak-proof critical zones.
The global medical protective apparel market is undergoing a rapid paradigm shift driven by stringent European regulations, environmental sustainability mandates, supply chain resilience strategies, and advancements in textile technology.
Global regulatory bodies are enforcing strict chemical restrictions, including zero tolerance for Per- and Polyfluoroalkyl Substances (PFAS), phthalates, and latex. Healthcare systems increasingly reject fluorocarbon-based water repellents in favor of eco-compliant, hypoallergenic hydro-repellent polymer matrices.
Hospitals are demanding lower carbon footprints without sacrificing sterility. The future lies in eco-designed protective apparel using single-polymer polyolefin compositions (monomaterial polypropylene) that allow streamlined post-surgical recycling and reduced bio-medical incinerator emissions.
Surgeon comfort directly impacts procedural precision. The industry is rapidly adopting active moisture-management nonwovens featuring high Air Permeability (EN ISO 9237) and elevated Thermal Resistance (ISO 11092) to eliminate sweating during long procedures under intense surgical lights.
Procurement departments are moving away from purchasing isolated apparel SKUs. Standardized single-use procedural packs combining drapes, gowns, and equipment sheaths customized to specific surgical specialties (orthopaedic, cardiac, ophthalmic) now dominate hospital tender requirements.
Post-pandemic healthcare procurement mandates dual-sourcing and partnerships with high-capacity export hubs like India. Facilities with vertical manufacturing integration—such as Surgeine’s four production units—ensure uninterrupted stock availability during regional emergencies.
Under global MDR frameworks, protective surgical apparel packaging must incorporate GS1-compliant Unique Device Identification (UDI) DataMatrix codes, enabling automated hospital inventory tracking, batch expiry verification, and digital patient record linkage.
Matching surgical risk exposure to the appropriate protective apparel grade ensures maximum infection prevention while eliminating budget waste caused by over-specification.
| AAMI PB70 Level | Material Construction | Hydrostatic Pressure (AATCC 127) | Impact Penetration (AATCC 42) | Viral Penetration (ASTM F1671) | Clinical Risk & Procedure Fit |
|---|---|---|---|---|---|
| AAMI Level 1 | Lightweight Spunbond / SMS (30–35 GSM) | Not Required | ≤ 4.5 g | Not Tested | Minimal fluid exposure; visitor isolation, routine ward rounds, ophthalmic consultations. |
| AAMI Level 2 | Standard SMS Polypropylene (40–45 GSM) | ≥ 20 cm H2O | ≤ 1.0 g | Not Tested | Low fluid exposure; suturing, minor diagnostic procedures, ENT examinations, tonsillectomy. |
| AAMI Level 3 | Heavy-duty SSMMS / Laminated (50–55 GSM) | ≥ 50 cm H2O | ≤ 1.0 g | Not Tested | Moderate fluid exposure; general surgery, laparoscopy, open cholecystectomy, arterial line placement. |
| AAMI Level 4 | Breathable Microporous Film Laminate / Reinforced Zones | ≥ 140 cm H2O | 0.0 g (Complete Imperviousness) | PASS (Resists Bacteriophage Phi-X174) | High fluid / blood pressure exposure; total joint arthroplasty, cardiovascular surgery, trauma, C-section. |
* All Surgeine protective surgical apparel products comply with EN 13795 requirements evaluating cleanliness, particulate linting (ISO 9073-10), burst strength (ISO 13938-1), and tensile strength (EN ISO 13934-1). Technical dossiers and batch certificates of analysis (CoA) are available upon request.
Surgical safety requires uncompromising consistency. At Surgeine Healthcare, our manufacturing philosophy is centered on total vertical control, eliminating third-party substrate vulnerabilities and delivering predictable quality shipment after shipment.
With 23+ years of technical specialized experience, our facilities serve leading healthcare systems across Europe, the Middle East, Asia-Pacific, and the Americas.
Operating four specialized manufacturing facilities, including a dedicated 2023 unit for custom surgical procedure packs equipped with ISO Class 100K and Class 10K cleanrooms.
Established in 2020, our in-house lab tests every raw material batch against international standards before cleanroom conversion occurs.
We streamline local market registration for global importers by providing complete regulatory technical dossiers.
Full private-label customization programs tailored to distributor branding and hospital group purchasing specifications.
Experience translates into technical reliability—demonstrated by our pioneering product developments and long-standing global compliance track record.
Regulatory compliance is an essential extension of protective surgical apparel quality. Surgeine Healthcare maintains a fully certified ISO 13485:2016 Quality Management System. Our protective surgical gowns, surgical drape sets, and procedure packs carry CE marking under EU MDR 2017/745—a rigorous certification updated in 2024.
We provide global distributors with comprehensive technical documentation packages, including Declarations of Conformity (DoC), biocompatibility reports (ISO 10993), EtO sterilization validation (ISO 11135), and packaging shelf-life stability data (ISO 11607).
CE (EU MDR)
ISO 13485
ZED Gold
Export House
BIS CertifiedSurgeine operates five dedicated product brands designed to meet distinct clinical needs across operating rooms, ICUs, and central sterile supply departments (CSSD).
Customised Procedure Packs
Surgical Drapes & Gowns
CHG Skin Antisepsis
Surgical Dressing Kits
OR Turnaround Solutions“Surgeine’s AAMI Level 4 surgical gowns provide our orthopaedic surgical team with total liquid security during total hip replacements. The breathability is unmatched, significantly reducing staff fatigue.”Dr. Rajiv Malhotra Chief Orthopaedic Surgeon, Apollo Hospitals
“As an NHS supply chain partner, receiving complete EU MDR technical files and ISO 13485 documentation upfront streamlined our regulatory clearance. Surgeine’s custom procedure packs are consistently top tier.”Ms. Sarah Thompson Procurement Director, European Healthcare Network
“We have partnered with Surgeine for private-label protective surgical apparel across the Gulf region for over five years. Zero lot recalls, immaculate cleanroom packaging, and exceptional commercial responsiveness.”Dr. Ahmed Al-Rashid Managing Director, Gulf Medical Supplies Ltd.
Key technical answers for hospital purchasing officers, tender specialists, and clinical infection control directors.
Our protective surgical apparel is classified under AAMI PB70 standard (Levels 1 through 4) based on rigorous fluid barrier testing. Level 1–3 garments are evaluated for fluid impact penetration (AATCC 42) and hydrostatic head pressure (AATCC 127). Our AAMI Level 4 gowns utilize monolithic microporous membrane laminates tested under ASTM F1671 to verify resistance to viral penetration (using Bacteriophage Phi-X174). Additionally, all products satisfy EN 13795 requirements for microbial cleanliness, bursting strength, and ultra-low linting (ISO 9073-10).
SMS (Spunbond-Meltblown-Spunbond) is a breathable polypropylene structure ideal for light to moderate fluid protection (AAMI Levels 1–3). Meltblown layers create a fibrous filter web that repels water droplets while allowing high air permeability. Microporous PE film laminate combines a spunbond nonwoven layer with a thin polymeric film containing micro-voids. It provides an absolute 100% barrier against liquid, blood, and viral particles under extreme pressure (AAMI Level 4), making it essential for high-fluid procedures like arthroplasty and trauma surgery.
Yes. Surgeine Healthcare specializes in full OEM and private-label manufacturing programs for medical distributors and group purchasing organizations (GPOs) in over 25 countries. OEM services include custom sleeve designs (raglan or set-in), specialized sleeve cuffs, reinforced chest/forearm zones, custom drape die-cutting, multi-lingual artwork adaptation, and GS1-compliant UDI barcode labeling tailored to your local health authority requirements.
Linting particles carry bacteria directly into surgical wounds. Surgeine utilizes 100% continuous filament virgin polypropylene fibers bonded via thermal calendars. All converting processes take place inside ISO Class 100K and Class 10K cleanrooms with automated vacuum debris extraction. Every fabric batch is tested via the Gelbo Flex method (ISO 9073-10) to verify particle count compliance well below EN 13795 maximum thresholds.
Every shipment is accompanied by complete batch traceability records. For market registration and customs clearance, we provide CE Declarations of Conformity under EU MDR 2017/745, ISO 13485:2016 certificates, Certificate of Free Sale (CFS), Batch Sterilization Certificates (EtO ISO 11135), and third-party independent lab test reports covering fluid barrier, biocompatibility (ISO 10993), and flame resistance (16 CFR Part 1610).
Absolutely. In 2023, Surgeine commissioned a dedicated production facility specifically for Customised Procedure Packs (CPTP). We assemble customized sterile trays combining protective gowns (AAMI Level 2, 3, or 4), procedure-specific drapes, hand towels, equipment sheaths, and surgical dressings in the exact presentation order specified by your hospital’s clinical protocol.
Partner directly with a certified manufacturer. Whether you require AAMI Level 4 surgical gowns, custom procedure pack configuration, or tender technical support, our global export team responds within 24 hours.
Talk with our medical nonwoven specialists to review material samples, barrier test reports, and factory-direct pricing for your market.
