Factory Product Showcase: Scalp Vein & IV Access Portfolio
CE & ISO 13485 Certified Medical Consumables Direct From ISO Class 8 Cleanroom Manufacturing Lines
14G – 26G Standard
Good Price 14g 16g 18g 20g 22g 24g 26g Sizes Different Types IV Cannula & Color Coding
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Sterile Pack OEM
Disposable IV Cannula Stainless Steel Sterile Pack Hospital Outpatient OEM
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Veterinary / Pet Care
Butterfly IV Cannula for Pet Intravenous Infusion & Small Animal Therapy
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Injection Port Type
CE ISO 13485 Medical 18G Butterfly Type IV Cannula Catheter With Wing Injection Port
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22G / 24G / 26G
Disposable 22g 24g 26g Animal IV Cannula / IV Catheter / IV Tube for Animals Cat Dog
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Flashback Chamber
B2B Wholesale Disposable Medical Sterile IV Cannula Catheter with Flashback Chamber
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Safety Shielded
Disposable 22G 24G Veterinary IV Cannula Safety Intravenous Catheter Medical Consumables
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Full Size Range
Veterinary IV Cannula Size 14g to 26g Intravenous Safety IV Cannula Catheters
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20+
Years Manufacturing Experience
100+
Global Export Markets
379+
Wholesale Distributors & Partners
100%
ISO 13485 & CE Compliance
1. Technical Engineering & Precision Architecture of Modern Scalp Vein Needles
In global medical device procurement, evaluating **top trusted scalp needle factories** requires a thorough understanding of metallurgical precision, polymer chemistry, and automated cleanroom assembly dynamics. Scalp vein needles (commonly referred to as **butterfly needles** or **winged infusion sets**) represent an indispensable category of single-use vascular access devices. Engineered for short-term venous access, blood sampling, and pediatric or geriatric fluid delivery, these devices demand extreme consistency in insertion force, flow dynamics, and structural sterility.
Our automated production processes integrate Japanese stainless steel cannula shafts, robotic siliconization, and high-precision polymer extrusion. Below is an anatomical breakdown of the primary engineering components that define top-tier scalp needle manufacturing:
Tri-Bevel Needle Point
Precision-ground 3-bevel needle geometry designed to minimize penetration force and reduce tissue trauma during venipuncture.
Ultrasonic Siliconization
Micro-coated medical-grade silicone lubricant applied via automated ultrasonic sprayers to ensure smooth needle advancement.
Flexible Butterfly Wings
Color-coded soft PVC or TPU wings according to ISO 6009 specifications, offering ergonomic tactile grip and secure skin anchorage.
Standard Size Color-Coding Matrix & Technical Dimensions
International procurement frameworks rely heavily on standardized gauge dimensions. The table below details the technical parameter matrix for standard scalp vein needle and butterfly IV access sets manufactured in our ISO Class 8 cleanrooms:
| Gauge Size |
ISO Color Code |
External Diameter (mm) |
Standard Needle Length |
Flow Rate (mL/min) |
Primary Clinical Application |
| 18G |
Pink / Green |
1.2 mm |
3/4" (19 mm) |
~90 mL/min |
Rapid blood transfusion, surgical fluid delivery |
| 20G |
Yellow / Purple |
0.9 mm |
3/4" (19 mm) |
~60 mL/min |
General adult IV therapy & outpatient blood draw |
| 22G |
Deep Blue |
0.7 mm |
3/4" (19 mm) |
~36 mL/min |
Paediatric infusion, oncology & fragile vein access |
| 23G |
Deep Blue / Sky Blue |
0.6 mm |
3/4" (19 mm) |
~25 mL/min |
Standard blood sampling & delicate venipuncture |
| 24G |
Medium Green |
0.55 mm |
1/2" (13 mm) |
~18 mL/min |
Neonatal care, small animals & veterinary use |
| 25G / 26G |
Royal Blue / Brown |
0.50 / 0.45 mm |
1/2" (13 mm) |
~10 - 14 mL/min |
Micro-infusion and specialized pediatric diagnostics |
Procurement Insight: When evaluating scalp vein set manufacturers, verify that needle cannula walls conform to ISO 9626 standards for thin-wall stainless steel tubing. Thin-wall construction delivers larger internal lumen diameters, increasing flow rates without inflating the external puncture footprint.
2. Global Sourcing Trends & Technological Evolution (2026–2030)
The global medical disposables market is undergoing structural shifts driven by regulatory tightening, safety mandates, and sustainability imperatives. Healthcare systems in North America, the European Union, the Middle East, and Latin America are restructuring their tender specifications to prioritize infection control and environmental compliance. Direct sourcing from qualified manufacturers requires aligning purchasing strategies with these overarching trends.
1. Mandated Sharps Safety Mechanisms
Global adoption of passive needle-shielding mechanisms (EU Directive 2010/32/EU and US OSHA Needlestick Safety Act) is replacing basic scalp needles with safety butterfly cannulas to prevent accidental needlestick injuries.
2. DEHP-Free & Phthalate-Free Polymers
Regulatory authorities are banning traditional plasticized PVC tubing containing DEHP. Modern scalp needle tubing uses TOTM-plasticized PVC or medical-grade Polyurethane (TPU) to prevent chemical leaching into lipid solutions.
3. Closed-System Blood Control Technology
Integration of automatic blood control septa inside catheter hubs stops blood leakage upon needle withdrawal, minimizing clinician exposure to bloodborne pathogens in emergency and intensive care settings.
Strategic Sourcing Advantage: Factory-Direct vs. Intermediary Trading
Healthcare procurement teams moving away from intermediary trading firms toward direct manufacturer partnerships gain distinct operational advantages. Direct factory sourcing provides full traceability of batch sterilisation records, raw material origin certificates, and customizable OEM packaging configurations.
3. Enterprise Superiority: Sonepat Cleanroom Manufacturing & ISO Governance
Lars Medicare Private Limited operates a world-class manufacturing campus in Sonepat (Haryana, India), engineered specifically to enforce zero-defect single-use medical device production. By consolidating tool design, high-speed injection moulding, needle sharpening, cleanroom manual and semi-automated assembly, and Ethylene Oxide (EO) sterilisation within a single quality-managed perimeter, we maintain absolute control over product integrity.
Key Infrastructure Pillars of Our Scalp Needle Factory
- In-House High-Precision Tool Room: Automated CNC micro-machining capabilities permit rapid prototyping of custom wing geometries, hub fittings, and multi-lumen connector configurations.
- ISO Class 8 Cleanrooms: Environmental control monitoring for particulate matter, positive differential air pressure, and microbial biocontainment meeting strict ISO 14644-1 parameters.
- Validated Ethylene Oxide (EO) Sterilisation Chambers: Industrial EO sterilisation cycles validated in accordance with ISO 11135, featuring complete gas aeration, biological indicator validation, and EO residue testing per ISO 10993-7.
- 100% Automated Optical Quality Control: High-resolution optical camera inspection arrays verify needle tip bevel integrity, wing alignment, and flash-chamber seal tightness at production line speeds.
Regulatory Compliance Footprint: Every export batch leaves our facility backed by an EC Declaration of Conformity, ISO 13485:2016 Quality Management Certification, Certificate of Free Sale (CFS), and batch-specific Certificates of Analysis (CoA).
Executive Governance & Quality Leadership
Direct leadership engagement ensures that OEM buyer specifications, private-label artwork design, and international regulatory dossiers are executed accurately and delivered on schedule.
Sanjay Goel
Managing Director
Over two decades of pioneer leadership in medical device engineering, cleanroom expansion, and global quality systems governance.
Sakshi Goel
Director
Directs global distributor networks, OEM brand partnerships, and international regulatory market expansion across 100+ countries.
Sameer Hingorani
Business Head – North America
Manages North American sales infrastructure, client logistics, and technical dossier support from our Ontario office in Canada.
4. Frequently Asked Questions (FAQ) for Global Procurement & Tender Buyers
Addressing core technical, regulatory, and supply chain questions commonly raised by hospital procurement officers, tender managers, and medical device importers.
Which regulatory certifications and documentation are supplied with each scalp needle shipment?
Every export consignment is supplied with comprehensive regulatory documentation, including a CE Certificate, ISO 13485:2016 Quality Management Certification, EC Declaration of Conformity, Certificate of Free Sale (CFS), and batch-wise Certificates of Analysis (CoA). Additionally, ethylene-oxide sterilisation cycle validation records and EO residue reports per ISO 10993-7 are included. Technical documentation files are formatted to support rapid product registration across Africa, Latin America, the CIS region, Southeast Asia, and the European Union.
Can you provide OEM private-label manufacturing for scalp vein sets and IV access devices?
Yes. We offer complete OEM and private-label manufacturing services for authorized distributors and brand owners. Our services encompass custom pouch and carton artwork design, multi-lingual Instructions for Use (IFU), UDI-ready barcoding, and custom packaging quantities (e.g., 50 pcs/box, 100 pcs/box, or bulk non-sterile components). Because tool room, molding shop, and cleanroom assembly lines are located within our single plant, customized wing colors, gauge mixes, and tube lengths can be manufactured without external vendor dependencies.
What are your minimum order quantities (MOQ) and production lead times for bulk export?
For standard catalogue items under neutral packaging, orders can begin at a minimum of one consolidated pallet. For OEM private-label production programs, the MOQ is calculated per SKU based on custom printing plates and raw material runs (typically starting at 50,000 units per gauge). Repeat orders for catalogue stock normally ship within 3 to 4 weeks. First-time OEM programs require 5 to 7 weeks to complete artwork proofing, sterilisation validation, and pre-shipment quality inspection.
Are your scalp vein sets and infusion lines available DEHP-free and latex-free?
Yes. Our scalp vein sets, IV infusion sets, and extension tubing can be manufactured using 100% DEHP-free, phthalate-free biopolymers and latex-free synthetic rubber components. These formulations are specifically designed for sensitive pediatric, neonatal, and oncology care where chemical leaching must be strictly prevented. Full biocompatibility test reports complying with ISO 10993 (cytotoxicity, systemic toxicity, and hemocompatibility) are provided upon request.
How do safety-engineered scalp needles protect healthcare workers against needlestick injuries?
Safety scalp needles feature an integrated passive or active locking shield that permanently encapsulates the sharp needle tip immediately upon withdrawal from the vein. Once activated, the locking mechanism prevents manual re-exposure or accidental skin puncture during disposal into biohazard sharps containers. This safety mechanism reduces clinical exposure to bloodborne pathogens and ensures compliance with institutional infection control protocols.
What Incoterms, export logistics ports, and payment structures do you support?
We routinely quote under FOB, CIF, CFR, and DDP terms based on buyer requirements. Sea consignments are routed through Nhava Sheva (Mumbai) and Mundra sea ports, while air freight is dispatched from Indira Gandhi International Airport (DEL) in New Delhi. Consolidated container loading and palletization take place directly at our Sonepat factory facility. Payment terms typically include Telegraphic Transfer (T/T) and Confirmed Irrevocable Letters of Credit (L/C at sight).
What are the recommended storage conditions to maintain sterilisation integrity over a 5-year shelf life?
Medical disposables must be stored in a clean, cool, and dry warehouse environment away from direct sunlight, extreme humidity, and chemical vapors, within a temperature range of 5°C to 40°C. Standard peel pouches maintain sterile barrier integrity for up to 5 years, provided the pouch sealing remains uncompromised. Always practice First-Expiry-First-Out (FEFO) inventory management and inspect individual blister pouches prior to clinical deployment.
Partner With a World-Class Scalp Needle Manufacturer
Upgrade your medical supply chain with factory-direct pricing, guaranteed batch consistency, and complete regulatory support. Connect directly with our international export management team to request technical datasheets, free evaluation samples, and customized OEM tender quotes.
