Syringe

Professional Disposable Sterile 3-Part Luer Lock PP Syringe

One Trusted Syringe Series, Every Capacity Your Business Needs

An FDA 510(k) cleared single-use syringe series molded from high-transparency medical-grade PP. Eight capacities from 1ml to 50ml, Luer Lock or Luer Slip tips, and fully customizable colors let you cover injections, fluid transfer and laboratory work with one supplier. EO gas sterilized, individually packed, and backed by full OEM/ODM support.

From $0.06

Unit Price (USD/pc)

2,000 pcs

Minimum Order (MOQ)

OEM / ODM

Printing, Tip & Packaging

~15 Days

Standard Lead Time

Get Bulk Quote Talk To Our Expert Directly

ISO 13485 CE Mark FDA Registered 100k Cleanroom

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.

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High-Transparency PP

Certified medical-grade resin with full batch traceability, clear enough for instant visual checks.

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3-Part Leak-Resistant Seal

Barrel, plunger and rubber gasket work together for secure sealing and steady dispensing pressure.

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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

Threaded twist-fit locks needles and connectors securely in place

No accidental detachment during injection or aspiration

Handles higher dispensing pressure with confidence

Compatible with all standard Luer Lock needles and accessories

Available on every capacity from 1ml to 50ml

Luer Slip Tip

(OEM Option)

Friction push-fit — fastest to connect and disconnect

Suits routine fluid transfer, irrigation and lab work

Compatible with standard Luer Slip needles and connectors

Available across the full capacity range on request

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.

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Class 100,000 Cleanroom Assembly

HEPA-filtered, temperature- and humidity-controlled production keeps every syringe free from contamination.

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FDA 510(k) Cleared (K212857)

FDA-reviewed syringe and needle families simplify your US market entry and tender applications.

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EO Gas Sterilization (ISO 11135)

Validated Ethylene Oxide cycles deliver a sterile, non-pyrogenic product, ready for immediate use.

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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.

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200 pc / Blister Box

Blister or PE pack with batch, production date and expiry printed — sterility protected until opening.

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1 0 Boxes / Carton

Sturdy export cartons, one capacity per carton, protect product integrity in transit.

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Express · Air · Sea

Flexible shipping methods matched to your order size, budget and timeline.

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~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.

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Clinical & Aesthetic Use

Injections, medication preparation and aspiration in hospitals, clinics and aesthetic practices — from 1ml skin boosters to routine intramuscular dosing.

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Laboratory & Research

Accurate measuring, sampling and reagent transfer, with a clear barrel that makes volume and air bubbles easy to check.

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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

Strictly follow professional aseptic operating procedures at all times.
Single-use only — re-sterilization or repeated use is strictly prohibited.
Do not use if the individual package is damaged or past the expiry date.
Use immediately after filling; do not store medication in the syringe for extended periods.
Dispose of used syringes as medical waste according to local regulations.
Store in a cool, dry, well-ventilated place, away from direct sunlight and corrosive gases.
Keep out of reach of children. For professional use only.

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

FAQ

Frequently Asked Questions

Quick answers for wholesalers, brand owners and clinic buyers.

We produce eight sizes: 1, 2, 3, 5, 10, 20, 30 and 50 mL. The 2,000-piece MOQ applies per capacity — you are welcome to combine several sizes in one shipment, and our team will plan the cartons accordingly.

Our syringe and needle families hold FDA 510(k) clearance (K212857), meaning the US FDA has reviewed the device and confirmed it is substantially equivalent to a legally marketed product. For you as a buyer, this supports faster registration, smoother customs clearance and stronger tender applications in the US market.

A Luer Lock syringe secures the needle with a threaded twist fit, preventing accidental detachment during injection or aspiration — the safer option for pressurized work. A Luer Slip syringe uses a friction push fit, which is quicker to connect for routine fluid transfer. Every capacity in this series can be ordered with either tip.

Yes, color is fully customizable. We mold with color masterbatch, so we can match the plunger, gasket and even the barrel tint to your brand palette or a clinical color-coding system. Share your Pantone reference or a physical sample and we will confirm the match during the sampling stage.

The barrel and plunger are molded from high-transparency medical-grade polypropylene (PP), sealed with a medical-grade rubber gasket. The product contains no natural rubber latex, and every sterile unit is EO sterilized, non-toxic and non-pyrogenic.

We supply ISO 13485 certificates, CE documentation, FDA 510(k) information, sterility reports and full batch traceability records. If you are registering in other markets, our in-house regulatory team prepares technical dossiers for KFDA, Anvisa and more.

Keep cartons in a cool, dry, ventilated room away from direct sunlight and corrosive gases. Stored correctly, the sterile barrier remains valid for 5 years from the production date printed on each individual pack.

Standard products ship within about 15 days. A first OEM order adds design confirmation and physical sampling, so plan for roughly 25–30 days from approved artwork. Repeat OEM orders return to the standard timeline.

Ready to Upgrade Your Product Line?

Get competitive OEM pricing for bulk needle-free injectors. Custom branding and packaging available with low MOQ.