3-Part Luer Lock Syringe Series, 1ml to 50ml
R&G Bio manufactures FDA 510(k) cleared single-use syringes for medical brands, clinics and distributors — one trusted series, every capacity your business needs.
Molded from high-transparency medical-grade PP, with eight capacities from 1ml to 50ml and Luer Lock or Luer Slip tips — proven 3-part design, factory-direct consistency.
Every unit is EO gas sterilized, batch-coded for full traceability, and produced in Class 100,000 cleanrooms under an ISO 13485 quality system. Review our certifications and compliance documents and see how we manufacture before you place a bulk order.
We support full OEM/ODM programs — custom specifications, private labeling and packaging built around your brand, with factory-direct MOQs and tiered wholesale pricing.
KEY SPECIFICATIONS
Technical Specifications
|
Product Name |
Professional Disposable Sterile 1ml–50ml 3-Part Luer Lock PP Syringe FDA 510(k) |
|---|---|
|
Type |
PP material syringe, 3-part design (barrel + plunger + rubber gasket) |
|
Capacity Options |
1 / 2 / 3 / 5 / 10 / 20 / 30 / 50 mL — 8 standard sizes |
|
Tip Type |
Luer Lock (featured) · Luer Slip option · central tip design |
|
Barrel & Plunger Material |
High-transparency medical-grade polypropylene (PP) |
|
Gasket |
Medical-grade rubber gasket — latex-free, secure sealing, leak resistant |
|
Color |
Fully customizable — plunger, gasket and barrel tint matched to your brand |
|
Graduations |
Clear, high-contrast printed scale for accurate volume reading |
|
Sterilization |
Ethylene Oxide (EO) gas sterilized — sterile, non-toxic, non-pyrogenic |
|
Regulatory Status |
FDA 510(k) cleared (K212857) for syringe and needle families · CE documentation available |
|
Production Standard |
Manufactured under ISO 13485 certified quality management system, Class 100,000 cleanroom |
|
Shelf Life |
5 years — production batch, date and expiry clearly marked on every pack |
|
Packaging |
Individual blister / PE pack; 200 pcs per box, 10 boxes (2,000 pcs) per export carton |
|
Unit Price |
From US $0.06 / pc (volume-based) |
|
MOQ |
2,000 pcs per capacity |
|
Disposability |
Single-use only — no re-sterilization, no reuse |
8
Capacities: 1–50 mL
510(k)
FDA Cleared · K212857
2
Tip Options: Lock / Slip
100%
EO Gas Sterilized
MATERIALS & CRAFTSMANSHIP
Medical-Grade PP, Proven 3-Part Engineering
A syringe is only as reliable as its materials and its seal. We combine certified medical-grade polypropylene with a precisely fitted rubber gasket, then verify every batch under an ISO 13485 quality system trusted by buyers in over 50 countries.
Clear PP Barrel, Secure Seal, Smooth Stroke
The barrel and plunger are injection-molded from high-transparency medical-grade PP — light, tough and clear enough to check liquid level and air bubbles instantly. The 3-part structure adds a rubber gasket between barrel and plunger, creating a tight seal that resists leakage and keeps the stroke smooth and controlled, from the smallest 1ml dose to a full 50ml draw.
High-Transparency PP
Certified medical-grade resin with full batch traceability, clear enough for instant visual checks.
3-Part Leak-Resistant Seal
Barrel, plunger and rubber gasket work together for secure sealing and steady dispensing pressure.
Fully Customizable Colors
Color-masterbatch molding matches your brand palette or clinical color-coding, with no surface paint to flake.
Luer Lock Tip
Featured & Preferred
Luer Slip Tip
(OEM Option)
Made in an ISO 13485 Factory, Cleared by the FDA
R&G BIO has manufactured medical-grade products since 2009. Our 23,000 m² facility runs fully automated molding and assembly lines inside Class 100,000 cleanrooms, with a defect rate below 0.02%. Our syringe and needle families hold FDA 510(k) clearance (K212857) — a strong foundation for your registration in the US and beyond.
Class 100,000 Cleanroom Assembly
HEPA-filtered, temperature- and humidity-controlled production keeps every syringe free from contamination.
FDA 510(k) Cleared (K212857)
FDA-reviewed syringe and needle families simplify your US market entry and tender applications.
EO Gas Sterilization (ISO 11135)
Validated Ethylene Oxide cycles deliver a sterile, non-pyrogenic product, ready for immediate use.
Global Compliance Support
Technical documentation for CE, FDA, KFDA and Anvisa registrations, handled by our in-house regulatory team.
Raw Material
Certified medical-grade PP resin from qualified suppliers, tested on arrival
Injection Molding
Precision molding of barrels and plungers across all 8 capacities
Scale Printing
High-contrast graduation printing, checked for accuracy and adhesion
Clean Assembly
Automated gasket fitting and assembly in Class 100,000 cleanroom
EO Sterilization
ISO 11135 validated EO gas cycle, sterility assured
Sealed Packing
Individual blister or PE pack with batch, date and expiry printed
PACKAGING & LOGISTICS
Sterile, Secure and Ready to Ship Worldwide
Each syringe is sealed in an individual sterile blister or PE pack, then packed 200 pieces per box and 10 boxes (2,000 pieces) per export carton. Our dedicated export team arranges express, air or sea freight to over 50 countries — standard orders ship within about 15 days.
📦
200 pc / Blister Box
Blister or PE pack with batch, production date and expiry printed — sterility protected until opening.
🗃️
1 0 Boxes / Carton
Sturdy export cartons, one capacity per carton, protect product integrity in transit.
✈️
Express · Air · Sea
Flexible shipping methods matched to your order size, budget and timeline.
⏱️
~15-Day Lead Time
Regular orders ship in about 15 days; OEM timelines confirmed with your quote.
APPLICATIONS & WORKING PRINCIPLE
How the 3-Part Syringe Works — and Where Each Size Fits
Pulling the plunger back creates a vacuum that draws liquid into the barrel; pushing it forward dispenses the liquid in a smooth, controlled flow. The rubber gasket seals against the barrel wall, so dosing stays accurate and leakage risk stays low — a simple principle that works across all eight capacities.
🏥
Clinical & Aesthetic Use
Injections, medication preparation and aspiration in hospitals, clinics and aesthetic practices — from 1ml skin boosters to routine intramuscular dosing.
🔬
Laboratory & Research
Accurate measuring, sampling and reagent transfer, with a clear barrel that makes volume and air bubbles easy to check.
💧
Fluid Transfer & Irrigation
Larger 20–50ml sizes handle irrigation, flushing and bulk fluid transfer efficiently in clinical and veterinary settings.
Choosing the Right Capacity
Matching syringe size to dose volume improves accuracy and reduces waste. As a rule of thumb, pick the smallest capacity that comfortably holds your target dose — the table below gives typical uses for each size in the series.
|
Capacity |
Typical Applications |
Common Users |
|---|---|---|
|
1 – 3 mL |
Small precise doses, skin boosters, mesotherapy, insulin-type dosing, vaccine preparation |
Aesthetic clinics, hospitals |
|
5 – 10 mL |
Routine intramuscular injections, medication reconstitution, sample collection |
Hospitals, clinics, labs |
|
20 – 50 mL |
Irrigation, flushing, bulk fluid transfer, veterinary dosing |
Hospitals, veterinary, industry |
USAGE & STORAGE
Professional Use in Four Simple Steps
For professional use only. Always follow your local regulations and established clinical protocols.
Select & Inspect
Pick the right capacity and tip type. Check the sterile pack is intact and in date before opening.
Connect & Draw
Attach the needle or connector — twist firmly on Luer Lock — then draw the required volume slowly.
De-air & Dispense
Hold tip-up, remove air bubbles, set the plunger to the exact graduation and dispense steadily.
Discard Once
Place the used syringe straight into a sharps container. Never reuse, never re-sterilize.
Important Safety & Storage Guidelines
OEM / ODM SERVICES
Build Your Own Branded Syringe Series
As a direct manufacturer, we customize nearly every part of the product — from capacity mix to full brand colors. Send us your logo and requirements; our team handles design, sampling, production and compliance documents. Standard orders ship in about 15 days after design confirmation.
Capacity Mix
Any combination of 8 sizes, 1–50 mL
Tip Type
Luer Lock or Luer Slip, central tip
Custom Colors
Plunger, gasket and barrel tint to your palette
Barrel Printing
Brand logo, custom scales and markings
Needle Matching
Matched sterile needles from our 510(k) family
Custom Packaging
Branded blister cards, printed boxes and cartons
Send Requirements
Tell us needle specs, colors, logo and packaging ideas
Design & Quote
We reply within 24 hours with pricing and design draft
Sample Approval
Physical samples made for your confirmation
Mass Production
Cleanroom production with full QC and batch records
Global Delivery
On-time shipping to 50+ countries with export support
Our Certifications
R&G Bio is an integrated manufacturer with verified FDA registration, ISO 13485 / ISO 9001 certification and EU RoHS compliance — the documentation your market actually requires.
FAQ
Frequently Asked Questions
Quick answers for wholesalers, brand owners and clinic buyers.
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Find Expert insights
About R&G Bio
Built on Precision.
Trusted Globally.
Where Precision Meets Medical-Grade Standards
ISO 13485 certified facility with ISO Class 100,000 cleanrooms. 316L surgical steel, complete traceability.
End-to-End Manufacturing Control
From needle configuration to sterile packaging, every step is precision-controlled with automated assembly and batch tracking.
Meeting International Regulatory Standards
CE Mark, FDA Registered, KFDA Approved, ISO 13485, RoHS Compliant. Full documentation for global market entry.
Trusted Tattoo Needle Manufacturer Since 2009
15+ years serving 50+ countries with premium cartridge tattoo needles and flexible OEM/ODM solutions.
OEM / ODM SERVICES
Contact us for wholesale pricing and custom configurations
Get In Touch
Request a Quotation
Tell us about your requirements and our team will respond within 24 hours with a detailed quote including pricing, lead times, and customization options.