Class 100K Cleanrooms
Manufactured inside environmentally monitored ISO Class 7 & Class 8 cleanroom facilities to guarantee minimal particle contamination before sterilization.
Manufactured in ISO Class 7 & Class 8 cleanrooms. Trusted by group purchasing organizations, hospital networks, and medical importers in over 25 countries worldwide.
Surgeine Healthcare engineers, manufactures, and exports medical single-use barrier products engineered for absolute operating room safety. Every category meets rigorous international quality standards, including AAMI PB70 Levels 1–4, EN 13795 compliance, and full traceability under EU MDR regulations.
Pre-assembled, specialty-specific surgical trays tailored to precise hospital clinical protocols. Streamlines operating room setup, reduces preparation time by up to 40%, and eliminates component packaging waste.
High-performance SMS and reinforced breathable surgical gowns providing verified liquid and microbial barrier protection. Designed with ergonomic raglan sleeves, ultrasonic seam sealing, and secure wrap-around closures.
Impermeable sterile drape systems engineered with high-capacity fluid collection pouches, reliable incise films, integrated cord organizers, and anti-glare reinforcement zones to maintain sterile integrity throughout prolonged procedures.
Single-use pre-operative skin preparation solutions incorporating 2% Chlorhexidine Gluconate (CHG) and 70% Isopropyl Alcohol (IPA). Delivers fast-acting, broad-spectrum microbial reduction with lingering antimicrobial protection.
Sterile, ready-to-use wound dressing packs containing high-absorbency non-woven swabs, anatomical drapes, precision forceps, and medical tape. Standardizes post-operative wound care and bed-side clinical procedures.
All-in-one operating theatre changeover kits designed to accelerate case turnover times between surgeries. Includes high-absorbency table sheets, armrest covers, headrest protectors, and waste containment bags.
Clear, tear-resistant sterile poly drapes engineered to protect sensitive medical electronics within the sterile field. Fits C-arms, surgical microscopes, ultrasound probes, camera heads, and Mayo stand tables.
Breathable protective clothing line including fluid-resistant isolation gowns, scrub suits, protective coveralls, bouffant caps, and anti-skid shoe covers designed for infection control across ICUs, wards, and sterile suites.
Specialized blood collection filter cards, safety lancets, desiccants, and moisture-barrier foil bags engineered for standardized neonatal metabolic screening, infectious disease surveillance, and toxicological bio-sampling.
End-to-end perioperative risk reduction range featuring sterile surgical scrub brushes, port protector disinfectant caps, vascular catheter stabilization devices, and microbial barrier drapes engineered to combat HAIs.
Pre-packaged chairside dental surgical drape kits containing specialized split drapes, tube holders, light handle covers, and patient drapes designed specifically for implantology, periodontics, and oral surgery.
Medical-grade polypropylene surgical holloware line, including graduated gallipots, kidney trays, sponge bowls, and procedure trays. Autoclavable, shatterproof, and chemical-resistant for sterile field organization.
Every surgical disposable leaving our plants undergoes rigorous barrier, tensile, and microbial safety testing to align with global health authority regulations.
| Certification / Standard | Regulatory Scope | Audit / Issuing Authority | Procurement Advantage for Overseas Buyers |
|---|---|---|---|
| ISO 13485:2016 | Medical Devices QMS | TÜV / Accredited Body | Full batch traceability, validated cleanroom production, risk management controls. |
| CE Marking (EU MDR 2017/745) | European Medical Device Reg. | Notified Body (EU) | Direct import clearance into European Union member states and accepting territories. |
| AAMI PB70 (Levels 1–4) | Liquid Barrier Performance | In-House & Third-Party Testing | Standardized fluid protection mapping from minor care (L1) to viral barrier surgery (L4). |
| EN 13795-1 Compliance | Surgical Drapes & Gowns | Validated Testing Labs | Guaranteed lint control, burst strength, and resistance to wet/dry microbial penetration. |
| BIS & Star Export House | Government Certification | Bureau of Indian Standards | Recognized sovereign export capability, high-volume capacity, and tender compliance. |
Over 23 years of specialized focus on perioperative infection prevention gives our manufacturing infrastructure unmatched technical depth and regulatory reliability.
Manufactured inside environmentally monitored ISO Class 7 & Class 8 cleanroom facilities to guarantee minimal particle contamination before sterilization.
Every lot is subjected to hydrostatic pressure, impact penetration, tensile strength, and bioburden tests to ensure total conformity with AAMI PB70 and EN 13795.
Full technical dossier support (STED), customized artwork, multi-language IFU printing, and bespoke packing configurations for international brand distributors.
Validated industrial sterilization cycles adhering to ISO 11135 and ISO 11137 standards, supported by full sterility assurance documentation.
Extensive experience fulfilling government tenders, GPO supply contracts, and private hospital network orders across Europe, Middle East, Americas, and Asia-Pacific.
Our dedicated regulatory team provides technical files, declarations of conformity, and free sale certificates to streamline product registration with your ministry of health.
Whether you require customized procedure packs tailored to specific surgical lists, private-label AAMI Level 4 gowns, or OEM CHG skin prep applicators, Surgeine Healthcare delivers certified quality with reliable lead times.
Contact our export specialists today for technical specifications, product samples, and competitive B2B quotation details.