AAMI Level 4 Reinforced
Reinforced Disposable Surgical Sterile Gown (SMMS / Multi-Layer)
Fluid-impermeable reinforcement zones for high-exposure orthopaedic and cardiovascular surgeries. Ultrasonic sealed seams.
Contact Us
Precision-engineered surgical disposable solutions optimized for high-fluid surgical environments, operating theatre efficiency, and infection control compliance across Saudi Arabian hospitals.
Fluid-impermeable reinforcement zones for high-exposure orthopaedic and cardiovascular surgeries. Ultrasonic sealed seams.
Contact Us
Breathable SMMS non-woven construction engineered for thermal comfort in high-temperature ambient clinical settings.
Contact Us
Class I certified fluid-shielding non-woven material for customizable surgical field drape boundaries and equipment wrapping.
Contact Us
Standard protection isolation and procedure gowns designed for high-turnaround outpatient units and general surgery.
Contact Us
Dual-purpose protective garment providing reliable barrier against bloodborne pathogens and aerosolized fluid exposure.
Contact Us
Polypropylene coated with polyethylene film ensuring complete liquid barrier protection during intensive surgical procedures.
Contact Us
Ergonomic fit with adjustable neck closure and soft elastic cuffs, optimizing sterility maintained in the surgical field.
Contact Us
High-tenacity non-woven SMS structure engineered for low linting, high abrasion resistance, and optimal fluid control.
Contact UsUnder the ambitious framework of Saudi Arabia's Vision 2030, the Kingdom's healthcare ecosystem is undergoing a monumental modernization phase. With the privatization of medical facilities, expansion of specialized tertiary care centers, and rigorous centralized procurement managed by NUPCO (National Unified Procurement Company), the demand for high-performance, SFDA-compliant sterile surgical drapes and protective apparel has reached an unprecedented scale.
Centralized purchasing through NUPCO requires strict adherence to international quality benchmarks (ISO 13485, CE MDR 2017/745) and localized packaging requirements. Manufacturers must supply verified technical files, batch sterility certificates, and clear Arabic/English labeling.
The Saudi Food and Drug Authority (SFDA) enforces stringent Medical Device Marketing Authorization (MDMA) pathways. Sterile drape exporters must provide documented evidence of sterilisation validation (ISO 11135 for EO gas) and biocompatibility testing (ISO 10993).
Surgical Site Infection (SSI) control is a top priority for Ministry of Health (MOH) and private hospital groups (e.g., Dr. Sulaiman Al Habib, Fakeeh Care). Utilizing advanced SMMS/SMMMS barrier drapes directly correlates with reduced post-operative complication rates.
Understanding fluid mechanics, hydrostatic head pressure, and microbial barrier resistance is essential for hospital infection control committees when choosing surgical drapes and gowns.
Modern high-performance surgical drapes utilize a 4-layer SMMS (Spunbond-Meltblown-Meltblown-Spunbond) or 5-layer SMMMS non-woven architecture. The outer Spunbond layers provide tensile strength, abrasion resistance, and structural integrity, while the inner dual Meltblown micro-fibrous layers act as a hydrophobic filter network capable of trapping bacteria, viruses, and aqueous particulate matter.
| Barrier Standard | Hydrostatic Pressure (cm H2O) | Impact Penetration (g) | Viral Resistance (ASTM F1671) | Recommended Clinical Application in KSA Facilities |
|---|---|---|---|---|
| AAMI PB70 Level 1 | > 20 cm | < 4.5 g | Not Required | Standard patient transport, visitor protective apparel, minimal fluid exposure. |
| AAMI PB70 Level 2 | > 30 cm | < 1.0 g | Not Required | Ambulatory care, short ophthalmic/ENT procedures, diagnostic biopsies. |
| AAMI PB70 Level 3 | > 50 cm | < 1.0 g | Pass | General surgery, laparoscopy, open abdominal procedures, emergency ward care. |
| AAMI PB70 Level 4 | > 100 cm (Laminated) | 0.0 g (No penetration) | Pass (Impermeable) | Arthroplasty, open-heart cardiac surgery, trauma interventions, high-irrigation cases. |
Surgical procedures vary significantly across specialties. Below are specialized drape configuration protocols tailored to major Saudi healthcare institutes such as King Faisal Specialist Hospital & Research Centre (KFSH&RC) and Ministry of Health surgical suites.
High-volume arthroplasty procedures generate massive fluid irrigation. Our localized orthopaedic drape packs incorporate heavy-duty AAMI Level 4 PE laminate zone reinforcements, integrated high-capacity fluid collection pouches with vacuum suction ports, and elasticity-engineered limb boots to maintain an absolute sterile field even during aggressive maneuverings.
Tailored for maternity hospitals in Riyadh, Jeddah, and Dammam, these drape sets feature 360-degree fluid funneling channels, integrated incise films impregnated with antimicrobial agents (e.g., CHG option), and soft fluid-resistant armboard covers ensuring patient safety and rapid postoperative room turnaround.
Designed for ultra-sensitive open-heart surgical theatres and cardiac cath labs. Features dual incise apertures, ultra-low linting non-woven materials complying with EN 13795 particle release metrics, and specialized cable holders to maintain organ-level sterile field purity.
For high-efficiency ambulatory surgery units in the Western and Eastern Provinces of Saudi Arabia. Lightweight, drape sets with micro-incise films and fluid collection bags configured to minimize setup time, cut pack-opening waste, and accelerate operating room changeover times (OR Swift methodology).
Exporting sterile medical devices to the Gulf Cooperation Council (GCC) market requires deep technical awareness of environmental storage challenges and localized procurement preferences.
Saudi Arabia’s ambient summer temperatures regularly exceed 45°C. Medical device packaging must maintain sterile barrier integrity (ISO 11607) despite high heat during customs clearance at King Abdulaziz Port in Jeddah or King Khalid International Airport in Riyadh. Our medical packaging utilizes tear-resistant Tyvek® and high-density medical grade pouch films verified by accelerated aging studies.
To combat hospital labor shortages and lower clinical preparation times, major Saudi hospital networks are moving away from individual component purchasing toward pre-assembled, procedure-specific sterile packs. As an OEM manufacturer with dedicated pack assembly cleanrooms commissioned in 2023, we offer complete component customization.
We support Saudi medical equipment distributors and GPOs with tailored private-labeling capabilities. From dual-language (Arabic/English) outer cartons and UDI-compliant barcoding to custom fold sequences matching local nursing preferences, our manufacturing infrastructure acts as an integrated extension of your local supply chain.
Since 2002, Surgeine Healthcare has maintained an uncompromising focus on perioperative infection prevention. Operating 4 specialized manufacturing facilities with in-house laboratory testing, we empower medical distributors globally.
Operating under an ISO 13485:2016 quality management framework. Product lines maintain unbroken CE Marking, including updated EU MDR 2017/745 certification achieved in 2024, alongside SFDA approval readiness, BIS certification, and ZED Gold recognition.
Our internal laboratory conducts routine lot-by-lot verification of hydrostatic pressure resistance, bursting strength, particle linting counts, and seam seal integrity in strict accordance with AAMI PB70 and EN 13795 requirements.
Featuring ISO Class 7 (10,000) and ISO Class 8 (100,000) cleanrooms, in-house hotmelt lamination, and automated pouch sealing. Every product batch is fully traceable from raw polypropylene resin to final sterile shipment.
Essential technical and regulatory answers for hospital procurement officers, tender managers, and medical supply distributors in KSA.
Yes. Our complete sterile surgical disposables portfolio is manufactured under ISO 13485:2016 and holds CE certification under EU MDR 2017/745. We provide Saudi importers and distributors with full technical dossiers (STED), biocompatibility reports (ISO 10993), sterilization validation data (ISO 11135), and Authorized Representative (AR) documentation required for SFDA Medical Device Marketing Authorization (MDMA).
Absolutely. Our dedicated customized procedure pack manufacturing unit (commissioned in 2023) specializes in building procedure-specific kits. We can configure drape dimensions, incise film sizes, gown barrier levels (AAMI Level 2–4), component placement order, and dual-language (Arabic/English) tray labels to precisely match MOH or private hospital tender specifications.
We utilize high-burst-strength medical grade peel pouches and heavy-duty 5-ply corrugated export master cartons lined with moisture-barrier liners. All packaging configurations undergo rigorous transport simulation testing (ASTM D4169) and thermal exposure trials to ensure sterile seal integrity remains 100% intact through Gulf climate transport and warehouse handling.
Standard production lead time for customized bulk orders is typically 3 to 4 weeks post packaging artwork confirmation. Logistics shipping times from our manufacturing facilities to King Abdulaziz Port (Jeddah) or Dammam Port average 12 to 18 days, ensuring rapid supply chain replenishment for contracted hospital tenders.