Sterile & Biocompatible
Processed under strict ISO Class 8 cleanrooms with EO sterilisation ensuring SAL 10^-6 for infection control.
Medical-grade sterile gauze, laparotomy sponges, abdominal pads, and customised surgical dressing kits manufactured to USP/EP specifications for global healthcare networks.
Processed under strict ISO Class 8 cleanrooms with EO sterilisation ensuring SAL 10^-6 for infection control.
100% surgical-grade pure cotton gauze designed for maximum exudate retention and minimal strike-through.
Full CE MDR technical files, USP/EP compliance, and multi-language OEM private-label packaging support.
Surgeine Healthcare manufactures a complete range of sterile surgical dressings engineered to safeguard operative wounds, control exudate, and mitigate surgical site infection (SSI) risks across inpatient and outpatient care environments.
Manufactured using 100% bleached surgical-grade cotton and hypoallergenic non-woven fabrics, our dressing solutions comply with international pharmacopeia standards (USP Type VII & EP specifications). With integrated X-ray detectable elements, folded non-fraying edges, and rapid wicking capability, Surgeine provides surgeons and wound care specialists with predictable clinical performance in every case.
From bulk sterile gauze swabs to procedure-matched dressing trays, our manufacturing infrastructure supports GPOs, national health authorities, and international distributors with verified regulatory dossiers and multi-lingual packaging.
Every item is produced in cleanroom conditions, available sterile (EO / Gamma) or non-sterile, in a comprehensive range of dimensions, plies, and packaging formats.
Soft, high-density 100% cotton woven swabs for wound cleansing, blood absorption, and tissue protection. Features tucked-in folded edges to eliminate fraying.
Heavy-duty surgical abdominal sponges pre-washed for maximum absorbency. Edge-stitched for structural integrity during deep cavity retraction and fluid control.
Multi-layer post-operative dressing pads featuring a thick absorbent cotton core wrapped in a non-woven, non-adherent backing to prevent wound stickiness.
Round folded cotton gauze pom-poms engineered without exposed cut edges. Ideal for skin antisepsis, intraoperative cavity swabbing, and deep wound packing.
Surgical-grade stabilization devices designed to anchor IV lines, PICC/CVC catheters, Foley catheters, and drain tubes, eliminating tape burn and accidental dislodgement.
Sterile OR needle counter boxes, blade removers, and magnetic transfer trays that enforce aseptic sharp counting protocols and prevent needlestick exposure.
All-in-one sterile wound care kits containing gauze, forceps, tray, drape, and refuse bag. Pre-packaged to support aseptic non-touch technique (ANTT).
Use this specification summary for hospital tender compliance, product selection, and regulatory cross-referencing.
| Product Category | Material & Construction | Pharmacopeia Standard | Sterilisation & SAL | Packaging Format |
|---|---|---|---|---|
| Sterile Gauze Swabs | 100% Bleached Cotton, 13/17/20 Threads per sq. cm | USP Type VII / EN 14079 | EO Gas / Gamma (SAL 10^-6) | Paper/Film Peel Pouch (2s, 5s, 10s) |
| Laparotomy Sponges | 100% Cotton pre-washed with BaSO4 radiopaque thread | EN 14079 / ISO 11135 | Ethylene Oxide (SAL 10^-6) | Sterile Pouch with Double Tracking Label |
| Combined Dressings | Absorbent Cotton Wool Core with Non-Woven Sheath | British Pharmacopoeia (BP) | EO Sterilised | Individual Sterile Barrier Pouch |
| Gauze Balls / Pom-Poms | 100% Absorbent Cotton without exposed raw edges | USP / EP Compliance | EO Gas Sterilized | Sterile Blister Packs / Bulk Non-Sterile |
| Custom Dressing Kits | Medical-grade non-woven, cotton components & trays | ISO 13485 / CE MDR 2017/745 | EO Sterilised (Validated) | Rigid Thermoformed Tray / Soft Peel Pouch |
* Detailed technical files, bio-compatibility test reports (ISO 10993), absorbency curves, and Certificates of Analysis (COA) are provided with every export shipment upon request.
Combining 23+ years of specialized infection prevention expertise with modern high-capacity automated cleanroom manufacturing.
Cleanroom processing and low-linting textile engineering reduce surgical site micro-contamination and foreign body reaction hazards.
Every raw material batch undergoes internal testing for sinking time, absorbency, grammage, fluorescence, and tensile strength before weaving.
Documented medical device safety compliance with complete technical dossiers available for fast regulatory import clearance in Europe and LATAM.
Turnkey private label manufacturing including customized box art, GS1 UDI barcoding, local language IFUs, and custom pouch dimensions.
High-volume manufacturing lines deliver contract stability, consistent batch-to-batch quality, and predictable container shipping schedules.
Optimized cotton sourcing and chlorine-free bleaching methods ensure reduced environmental impact without compromising clinical purity.
Surgeine surgical dressings are manufactured under ISO 13485:2016 quality management standards and carry CE certification under EU MDR 2017/745. They strictly conform to USP/EP medical gauze pharmacopeia requirements, EN 14079 absorption standards, and ISO 11135 Ethylene Oxide (EO) sterilization requirements with a Sterility Assurance Level (SAL) of 10^-6.
Yes. Our laparotomy sponges and surgical gauze packs feature heat-bonded or woven X-ray detectable barium sulphate threads (>60% BaSO4 content) that remain securely attached during high-fluid procedures, ensuring radiopaque visibility under intraoperative fluoroscopy to prevent retained surgical sponges.
Yes. We specialize in OEM and private-label production for medical distributors, hospital networks, and Group Purchasing Organizations (GPOs). Dressing pack components, gauze ply, sizes, tray configurations, multi-lingual sterile packaging artwork, and barcodes are fully customizable to meet regional health authority regulations.
Our surgical gauze products utilize 100% pure bleached cotton yarns with all folded edges turned inward to eliminate raw fringe. Controlled washing and thermo-mechanical processing in Class 100,000 (ISO Class 8) cleanrooms significantly cut particle shedding and lint accumulation in open surgical sites.
Partner with an ISO 13485 and CE MDR certified manufacturer for your hospital supply chain, OEM program, or national tender submission. Our export regulatory team delivers fast sample dispatch and comprehensive technical documentation.