SFDA & CE / EU MDR Certified Supplier

Hemostatic Gauze Supplier & Exporters in Saudi Arabia

High-Purity Oxidized Regenerated Cellulose (ORC), PGA Absorbable Dressings & Advanced Surgical Wound Closure Solutions for KSA Hospitals & Healthcare Tenders

ISO 13485 & WHO-GMP Certified Manufacturing

Export-Grade Surgical Hemostatic Gauze & Absorbable Materials

Engineered for rapid intraoperative hemostasis, superior tissue biocompatibility, and smooth bio-absorption across Saudi Arabia’s leading medical centers.

Absorbable PGA Veterinary Surgical Suture Absorbable PGA PGLA 910 Sterile Animal Suture

Veterinary & Surgical Absorbable PGA / PGLA 910 Sterile Materials

Precision-braided synthetic absorbable suture with smooth polycaprolactone coating ensuring predictable tensile strength retention for deep tissue closure.

USP 8-0 to 2 EO Sterilized 75-Day Absorption
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High Tensile Polyglycolic Acid Absorbable Braided Surgical Suture XY-POX05

Polyglycolic Acid (PGA) Absorbable Braided Surgical Suture Series

100% Polyglycolic acid construction providing high initial knot security, minimal tissue reaction, and fast hydrolytic degradation in general procedures.

High Pull-out Strength Violet / Undyed CE Marked
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Hemostatic Dressing Medical Absorbent Wound Suture Waterproof Breathable Silicone Foam Wound Dressing

Medical Absorbent Hemostatic & Silicone Foam Wound Dressing

Multilayer absorbent silicone foam dressing optimized for fluid management, rapid bleeding control, and gentle non-adherent removal in trauma care.

Waterproof Exudate Control Soft Silicone
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Polyglactin 910 Absorbable 3-0 4-0 Polyglactin 910 Chromic Catgut Surgical Suture

Absorbable Polyglactin 910 & Chromic Catgut Surgical Assemblies

Engineered with sharp stainless-steel needle attachments for visceral ligation, vascular control, and subcutaneous wound alignment.

USP 3-0 / 4-0 75cm Strand Catgut & PGLA
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Surgical Kit Risenmed Medical Consumables Absorbable Surgical Sutures Kit

Hospital Consumables Absorbable Polyglactin 910 Surgical Kits

Sterile multi-pack suture trays formulated for operating room efficiency during emergency surgeries and routine OB/GYN procedures.

Hospital Grade PGLA 910 Double Peel Foil
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Monofilament High Tensile Strength Absorbable PGA Suture Thread CE Certified

High Tensile Strength CE-Certified Absorbable PGA Surgical Threads

Advanced synthetic filament featuring superior knot holding capability, predictable absorption profiles, and 5-year shelf-life stability.

CE & ISO 13485 Low Drag Bulk Export
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Needle Combination Medical Absorbable POLYGLYCOLIC ACID PGA Surgical Suture with Needle

Precision Needle Medical PGA Absorbable Surgical Wound Closures

Integrated siliconized stainless-steel needle swaged onto 100% PGA threads to ensure seamless penetration and minimal tissue trauma.

Taper Point / Cutting PGA Hydrolysis OEM Available
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Veterinary & Clinical RUNPHY HC002 Medical Veterinary Suture Absorbable PGA Suture

Disposable Medical & Veterinary Absorbable PGA Surgical Suture Series

Multi-purpose sterile PGA suture line developed for clinical surgery, trauma repair, and specialty surgical centers across the GCC region.

Disposable Pack High Biocompatibility Fast Shipment
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2 - 4 Min
Average Hemostasis Time
100%
Plant-Based Bio-Absorption
50+
Global Export Destinations
SAL 10⁻⁶
Validated EO Sterility Level
Industry Technical Whitepaper

Mechanism of Action: Advanced Hemostatic Gauze in Surgical Practice

A comprehensive examination of Oxidized Regenerated Cellulose (ORC), bio-absorption pathways, and antimicrobial efficacy in high-acuity operative environments.

Intraoperative Clot Formation & Physical Matrix Effect

When applied directly to oozing capillary, venous, or small arterial bleeding sites, bio-absorbable hemostatic gauze—specifically constructed from Oxidized Regenerated Cellulose (ORC)—swells upon contact with blood. It rapidly transforms into a dark, viscous gel matrix. This physical gel structure serves as a artificial scaffold, consolidating blood platelets, accelerating the activation of the intrinsic coagulation cascade, and forming a stable fibrin plug within 120 to 240 seconds.

  • Immediate matrix gelation upon contact with blood serum
  • Conforms flawlessly to irregular surgical cavities and bleeding beds
  • Maintains mechanical stability without dislodging during irrigation

Low-pH Bactericidal Activity & Complete In-Vivo Absorption

Unlike non-oxidized cotton dressings, high-grade ORC hemostatic gauze creates a localized acidic microenvironment (pH < 4.0) around the wound surface. This temporary drop in micro-environmental pH exerts a broad-spectrum bactericidal effect against both Gram-positive and Gram-negative pathogens, including MRSA, MRSE, and Pseudomonas aeruginosa. The material undergoes enzymatic hydrolysis and enzymatic phagocytosis, achieving complete absorption in tissue within 7 to 14 days without leaving granulomatous residues.

  • Reduces risk of surgical site infections (SSIs) in contaminated fields
  • Fully bio-absorbable with minimal tissue inflammatory response
  • No secondary trauma—zero need for painful dressing removal
Localized Clinical Integrations

Hemostatic Gauze Application Scenarios Across Saudi Arabian Healthcare

Engineered to satisfy the rigorous clinical demands of KSA Ministry of Health (MoH) hospitals, military medical services, and specialized private surgical centers.

Cardiovascular & Thoracic Surgery

In high-risk coronary artery bypass grafting (CABG) and aortic valve procedures at premier institutes such as King Faisal Specialist Hospital & Research Centre in Riyadh, controlling diffuse vascular suture line bleeding is paramount. Our ORC hemostatic gauze provides pliable, immediate localized bleeding control on cardiac suture lines and vascular anastomoses.

Emergency Trauma & Military Medicine

Deployment with KSA Emergency Medical Services (Red Crescent) and Armed Forces Medical Services across tactical operations requires portable, weather-resistant hemostatic agents. Our vacuum-sealed, high-density hemostatic gauze packs stop arterial hemorrhage rapidly in severe blast trauma, gunshot wounds, and highway emergency trauma scenarios prior to hospital admission.

Obstetrics & Gynecological Surgery

During Cesarean sections, hysterectomy procedures, and pelvic reconstructive surgeries across major maternity units in Jeddah and Dammam, heavy uterine and pelvic oozing must be managed swiftly. The conformability of bio-absorbable PGA and ORC gauze allows surgeons to pack deep pelvic beds cleanly, preventing postoperative hematomas.

Neurosurgery & Spine Reconstructions

Micro-neurosurgical procedures demand ultra-pure hemostats that induce negligible tissue expansion. Our dense-weave ORC gauze can be tailored into tiny cottonoid-style strips to arrest epidural venous oozing and cranial resections without exerting unwanted compressive mass effect on adjacent neural tissue.

Dental, Maxillofacial & Implantology

In specialized dental hospitals and oral surgery clinics throughout the Kingdom, post-extraction socket hemorrhage in anticoagulated patients presents a daily challenge. Pre-cut absorbable hemostatic plugs instantly stabilize socket clots and degrade naturally, facilitating rapid bone regeneration.

Laparoscopic & Minimally Invasive Surgery (MIS)

Passing hemostatic agents through 5mm or 10mm laparoscopic trocars requires high flexural resilience. Our gauze strips roll smoothly into compact cylinders, unroll effortlessly inside the peritoneal cavity, and adhere firmly to gallbladder beds or liver resection sites.

Market Intelligence & Local Dynamics

Saudi Arabia Healthcare Trends & Regulatory Compliance (Vision 2030)

Strategic context for medical device procurement managers, tender agents, and hospital directors operating within the Saudi Arabian market.

SFDA Approval & MDMA Registration Alignment

The Saudi Food and Drug Authority (SFDA) maintains stringent regulatory oversight on Class III medical devices, including absorbable hemostatic dressings and surgical sutures. Exporters must provide complete technical dossiers including ISO 13485:2016 verification, CE mark certification under EU MDR 2017/745, and comprehensive biocompatibility evaluation reports (ISO 10993 series). Our products are supported by complete regulatory compilation packages to streamline Medical Device Marketing Authorization (MDMA) approvals.

NUPCO Centralized Procurement Integration

The National Unified Procurement Company (NUPCO) controls centralized healthcare tenders for MoH hospitals, National Guard Health Affairs, and University Hospitals. NUPCO tenders require rigid compliance with standardized packaging specs, double-peel sterile barrier systems, Arabic/English bilingual labeling, and extended sterile shelf-life validation. Our supply chain is structured to fulfill large-volume NUPCO tender commitments with robust safety stock margins.

Saudi Vision 2030 Healthcare Transformation

Saudi Vision 2030 is driving massive expansion in private healthcare infrastructure, day-surgery centers, and specialized trauma networks across Riyadh, Mecca, Medina, and the Eastern Province. This growth has created unprecedented demand for advanced surgical consumables that minimize operating room time, shorten hospital length-of-stay (LOS), and lower overall complication rates.

Climatic Resilience & Desert Supply Chain Logistics

Ambient temperatures during transport across the Arabian peninsula can exceed 45°C. Hemostatic gauze and absorbable synthetic materials must maintain structural integrity under demanding environmental conditions. Our products undergo rigorous accelerated stability testing and are packaged in ultra-protective aluminum foil moisture-barrier packaging to ensure complete stability during transit to Jeddah or Dammam ports.

Technical Comparison & Product Matrix

Hemostatic Gauze & Absorbable Suture Specification Matrix

Detailed performance parameters engineered for surgical procurement officers and clinical audit committees.

Material / Material Code Composition Hemostasis Time In-Vivo Absorption Antimicrobial Efficacy Primary Clinical Indications
ORC Standard Gauze 100% Oxidized Regenerated Cellulose 2 – 4 Minutes 7 – 14 Days High (Bactericidal pH < 4.0) General surgery, trauma, visceral resections
ORC Fibrillar Hemostat Layered Oxidized Regenerated Cellulose 1.5 – 3 Minutes 7 – 14 Days High (Wide pathogen clearance) Neurosurgery, spinal oozing, orthopedic beds
PGA Absorbable Thread 100% Polyglycolic Acid (Braided) Mechanical Ligation 60 – 90 Days Standard Inert Biocompatibility Fascial closure, gastrointestinal anastomosis
PGLA 910 Synthetic Polyglactin 910 (Coated) Mechanical Ligation 56 – 70 Days Available with Triclosan Option OB/GYN, subcutaneous tissues, muscle repair
Silicone Foam Hemostatic Medical Silicone & Hydrophilic Polymer Immediate Pressure Clotting External / Non-Absorbable Bacteriostatic Barrier Exudative wounds, superficial trauma, burn care
Procurement & Sourcing FAQ

Frequently Asked Questions by Saudi Arabian Medical Buyers

Direct responses regarding regulatory paperwork, sample evaluations, NUPCO tendering, and direct export logistics to Saudi Arabia.

What documentation is supplied to support SFDA registration in Saudi Arabia?
We provide a complete regulatory technical file required for SFDA Medical Device Marketing Authorization (MDMA). This includes our ISO 13485:2016 quality management certificate, CE Mark Certificate under EU MDR 2017/745, Certificate of Free Sale (CFS), Certificate of Analysis (CoA) for each batch, biocompatibility test data per ISO 10993 (cytotoxicity, sensitization, systemic toxicity), and ethylene oxide (EO) sterilization validation reports per ISO 11135.
Can you provide customized sizes and private label packaging for KSA distributors?
Yes, full OEM and private-label manufacturing solutions are available for registered Saudi medical distributors. We customize gauze dimensions (e.g., 5cm x 7.5cm, 10cm x 20cm, fibrillar pads), primary foil pouch printing, outer box packaging, and multi-language Instructions for Use (IFU) incorporating Arabic and English, along with GS1 DataMatrix / UDI barcodes compliant with SFDA traceability mandates.
What is the shelf life and storage requirement for hemostatic gauze in Middle Eastern climates?
Our hemostatic gauze products possess a validated 5-year sterile shelf life from the date of manufacture. Each unit is hermetically sealed in heavy-duty aluminum foil inner pouches designed to withstand high humidity and ambient temperature fluctuations up to 30°C (with thermal tolerance spikes up to 50°C during shipping). Standard climate-controlled warehouse storage below 25°C is recommended for long-term retention.
What are the typical export lead times to major Saudi Arabian ports like Jeddah Islamic Port or King Abdulaziz Port Dammam?
Standard catalog items ship within 2 to 3 weeks following order confirmation. Private label or custom OEM orders typically require 4 to 5 weeks for initial artwork sign-off, production, EO sterilization, and release testing. Ocean freight transit from our hub to Jeddah or Dammam port takes approximately 12 to 18 days, while urgent air freight shipments arrive at King Khalid International Airport (Riyadh) within 3 to 5 business days.
How does Oxidized Regenerated Cellulose (ORC) compare to gelatin or collagen hemostats?
Oxidized Regenerated Cellulose (ORC) offers distinct advantages over animal-derived gelatin or collagen sponges: it is 100% plant-based (eliminating viral transmission or BSE risks), features an inherent low pH that provides immediate bactericidal properties, absorbs completely without swelling excessively (making it far safer in confined neural or spinal spaces), and leaves no persistent foreign-body residues.
Do you supply evaluation samples for hospital clinical trials and tender reviews?
Yes, we supply sterile evaluation sample boxes along with technical data packages to qualified hospital procurement committees, tender agents, and authorized medical importers across the Kingdom of Saudi Arabia. Please reach out via our contact interface to arrange sample delivery.
Manufacturing Authority & Quality Systems

Why Leading Global Procurement Teams Partner With Us

Uncompromising commitment to single-site cleanroom manufacturing, 100% batch traceability, and global compliance standards.

Class 100,000 Cleanroom Production

All weaving, chemical oxidation, needle attachment, and pouch packaging operations take place inside ISO Class 7 (Class 100,000) controlled cleanroom environments, preventing particulate and bioburden contamination before final sterilization.

Full Chain-of-Custody Traceability

Every single box exported carries a unique lot number that provides complete backwards traceability to raw cellulose polymer batches, oxidation cycle logs, needle wire tensile tests, and ethylene-oxide sterilizer charts stored for 11 years.

Zero-Defect Quality Control Standard

From 100% pull-out testing on needle-suture swages to visual micro-inspection of seal integrity on every primary foil pouch, our internal quality assurance protocols exceed USP and European Pharmacopoeia (EP) monograph standards.

Request Factory-Direct Quotations & SFDA Dossiers

Partner with a certified hemostatic gauze manufacturer & exporter dedicated to supplying high-performance surgical materials across Riyadh, Jeddah, Dammam, and the greater GCC region.