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Industry Knowledge
Jiangsu Zhiyu Medical Instrument Co., Ltd. is a China-based Insulin Syringes manufacturer supplying sterile single-use insulin syringes for subcutaneous insulin delivery in clinical, pharmacy and home-care channels. Our range covers 0.3 mL, 0.5 mL and 1 mL U-100 configurations with fixed 27G–31G needles, supported by OEM/ODM packaging, specification extension and project-based coordination from sampling to volume production.
A Focused Range Within Our Medical Consumables Portfolio
Insulin syringes sit inside our broader Medical Consumables programme, alongside Disposable Syringes, hypodermic needles, butterfly needles and infusion sets. The category is defined by small-volume precision dosing rather than general injection use: unit graduations, fixed-needle construction and short, fine needles are the design priorities.
We manufacture this family for distributors, pharmacy chains, chronic-care programmes and private-label brand owners. Because insulin administration is a repeated daily behaviour, our production planning treats scale consistency, clear scale printing and packaging suitable for pharmacy and home distribution as core requirements rather than optional features.
Standard Configurations and Specification Range
The mainstream commercial combination is a 0.3/0.5/1 mL barrel with a fixed needle, 27G–31G gauge and short needle length such as 8 mm or 12.7 mm. Our proposal is built around the working concentration, the target patient or channel and the required unit scale.
| Barrel Volume | U-100 Unit Scale | Typical Needle Gauge | Typical Needle Length | Application Fit |
|---|---|---|---|---|
| 0.3 mL | 30 units | 29G–31G | 8 mm | Low-dose regimens, paediatric and fine titration |
| 0.5 mL | 50 units | 28G–31G | 8 mm / 12.7 mm | General adult subcutaneous dosing |
| 1 mL | 100 units | 27G–30G | 12.7 mm | Higher-volume regimens, clinical and hospital supply |
| Concentration-specific | Matched to U-40 / U-100 / U-500 | 27G–31G | 8 mm / 12.7 mm | Markets where scale and concentration must be locked together |
Scale and concentration must be treated as one specification. A U-100 barrel marked in units is not interchangeable with a volumetric syringe when a different concentration is dispensed, so we confirm the concentration system before printing plates or moulds are committed.
Materials, Needle Geometry and Injection Comfort
- Barrel and plunger in medical-grade polymer with a clear wall for reading the unit scale.
- Fixed needle construction to remove dead space and reduce dose loss in small-volume injections.
- Short, thin needle geometry for subcutaneous delivery, with 8 mm and 12.7 mm as the common lengths.
- Luer or fixed-needle variants evaluated against the intended channel and handling routine.
- Single-use, sterile presentation with EO sterilisation and lot identification on the unit pack.
Manufacturing, Capacity and Quality Control
Zhiyu operates a collaborative production system covering injection moulding, assembly, testing and packaging on related product lines, with automated equipment, online inspection and standardised quality control supporting batch consistency. Our insulin syringe line is produced under cleanroom conditions with in-line inspection and retained samples managed through shelf life.
For applicable product lines we hold ISO 13485:2016 certification, EU MDR quality management system certification covering insulin syringes among other products, FDA establishment registration and device listing, and FDA 510(k) clearance for specified sterile syringe and hypodermic needle products. Regulatory scope differs by product and target market, so the applicable documents are confirmed against the specific item and destination before a project is released.
OEM/ODM, Packaging and Private Label
Beyond standard supply, we support product matching and assortment planning, specification confirmation and extension, packaging adaptation and development, private-label support, structural optimisation and, for suitable projects, mould development and customised product development. This allows a distributor or brand owner to move from a product concept through sampling and validation into volume production without changing manufacturing partner.
Packaging can be planned as neutral bulk, colour box, blister or PE bag formats with multilingual label design, matched to pharmacy, hospital or home-care distribution. The Insulin Syringes range is also available alongside related single-use items such as Medical Needles & IV Products for consolidated shipments.
Information We Use to Configure Your Solution
To prepare a configuration and quotation we work from the following project inputs. Early clarity on concentration, scale and packaging shortens the path from evaluation to sampling.
- Barrel volume and unit scale, plus the insulin concentration system in use.
- Needle gauge, needle length and fixed or separate needle preference.
- Target market and the regulatory documents required for registration or tender.
- Packaging format, label language and whether private label is needed.
- Estimated order quantity, delivery schedule and repeat-order expectation.
- Any drawings, reference samples or competitor samples that define the target product.
Installation, Handling and Serviceability
Insulin syringes are supplied sterile and ready for use, so the practical requirements are storage, handling and traceability rather than on-site installation. We recommend storage in a dry, protected area within the labelled temperature range, with stock rotated by lot and packaging kept intact until use.
For repeat programmes we maintain inspection records, quality reports and retained samples, and we coordinate spare or replacement supply through the same project channel. Documentation and training material can be prepared around the agreed specification so that receiving, storage and dispensing staff work from one reference.
Frequently Asked Questions
Which insulin syringe sizes does Zhiyu manufacture?
We produce 0.3 mL, 0.5 mL and 1 mL barrels corresponding to 30, 50 and 100 units in the U-100 system, with fixed needles in the 27G–31G range and common lengths of 8 mm and 12.7 mm. Other combinations are evaluated as specification extensions.
Can you supply syringes matched to a specific insulin concentration?
Yes. Scale and concentration are confirmed together at the start of the project so that the printed unit markings match the concentration the product will be used with. This is particularly relevant where U-40, U-100 or U-500 systems coexist in one market.
Do you support OEM and private-label insulin syringe projects?
We support OEM/ODM cooperation covering packaging adaptation, specification extension, private-label support, structural optimisation and, for applicable projects, mould development and customised product development, with coordination from sampling through to volume production.
What quality and regulatory documents are available?
For applicable product lines we hold ISO 13485:2016 certification, EU MDR quality management system certification, FDA establishment registration and device listing, and FDA 510(k) clearance for specified sterile syringe and hypodermic needle products. The applicable documents are confirmed against the specific product and target market.
How is batch consistency controlled during production?
Production runs under cleanroom conditions with automated equipment, in-line inspection and standardised quality control procedures. Incoming material, in-process and final product inspection are recorded, and retained samples are kept through shelf life for traceability.
What information is needed for a quotation?
Barrel volume, unit scale, needle gauge and length, packaging format, target market, estimated quantity and whether private label is required. Drawings, photos or reference samples help us confirm the specification more precisely before sampling.
