Medical Injection Molding Services

Single-use medical devices like speculums, probes, and needle sheaths, molded in named, traceable resins on tooling we build and maintain ourselves, inspected batch by batch, and packed ready for your market.

30 yrs
Since the first mold in 1996
ISO
9001:2015 certified
10
Cavities on our needle sheath tool
100%
Batches inspected & documented
Home/Industries/Medical

Medical Device Molding

Parts That Touch Patients Don't Get a Second Chance

A speculum with a rough edge hurts someone. A needle sheath molded from an unverified resin lot is a recall waiting to happen. Medical buyers already know this. What they look for is a supplier who runs production with that in mind every single day.

We learned that discipline the hard way, on the intraoral dental parts we've molded since 1996, and we run our medical work to the same standard:

  • Named resins only. Your part is quoted and molded in a specific grade such as GPPS, PC, or LDPE, never in an "equivalent material," and the resin lot is traced on every batch.
  • Edges checked by hand. Parts that contact tissue must feel smooth to the touch, which goes beyond a visual pass.
  • Tooling fixed at the root. If a defect shows up, we correct the mold instead of sorting parts at the table. We can do that because the molds are ours, built in-house.
  • Your brand, your market. Much of what we mold ships under our customers' own labels. NDA before you send a file, no customer names on our site.
Injection molded single-use vaginal speculum in clear GPPS
Single-use devices in clear GPPS, molded, inspected, and packed under one roof.

Medical Parts We Mold

Real Parts From Our Production Floor

These are not stock photos. Every part here is a program running on our machines today, listed with its actual material and tooling.

Single-use vaginal speculums in three sizes, injection molded in GPPS

Vaginal Speculums

  • MaterialGPPS, water-clear for visibility
  • SizesS / M / L on dedicated molds per size
  • CriticalSmooth edges and hinge action checked on every batch
Injection molded medical probe in polycarbonate

Probes

  • MaterialPolycarbonate (PC) for stiffness and impact strength
  • FeatureSpiral geometry molded in one shot, with no machining needed
  • CriticalDimensional consistency shot to shot
Injection molded needle sheaths in LDPE, 10-cavity tooling

Needle Sheaths

  • MaterialFlexible LDPE for a secure fit on the hub
  • Tooling10-cavity mold for high-volume runs
  • PackingBoxed or bagged to your spec, ready for export

Production Capabilities

The Numbers Behind Every Medical Batch

Any supplier can claim capability. Here are the specifics a sourcing engineer actually checks: machines, tolerances, tooling, volumes, and the records that back them up.

50T to 1,000T Machines

From a fingertip-sized LDPE needle sheath to large device housings, the press is matched to the part, whether it runs in our Ningbo factory or at our partner facility in Hefei.

±0.05 mm Standard Tolerance

Down to ±0.02 mm on critical features such as speculum hinge zones and sheath-to-hub fits, verified at first article and monitored through the run.

Our Own Mold Shop

100+ production molds designed, built, and maintained in-house in P20, H13 and 718H steels. If a dimension drifts, we correct the tool in days rather than waiting in a subcontractor's queue.

Multi-Cavity Tooling

Our needle sheath runs on a 10-cavity tool; speculums run size-dedicated molds. Cavity count is engineered around your annual volume, and we show you the math.

No MOQ, Up to 1M+ a Year

Pilot runs of any size to qualify your device, then scale on the same tool. 13M+ parts shipped across programs that reorder year after year.

Inspected & Documented

FAI on every new tool, edge and dimension checks per batch, resin lots traced. When your auditor asks, the answer comes from records we already keep.

What Can We Mold for You?

Medical parts split into two families: parts that touch the patient, and parts that make the equipment work. We run both, and we know which rules apply to each. Send a drawing or a sample and we'll tell you honestly whether it's a fit.

Send Your Drawing

What medical parts demand:

Smooth, burr-free edges on every tissue-contact surface Named, lot-traced resins suitable for medical use Batch-level inspection with records your auditor can pull

Parts we mold today, and what we can take on:

Vaginal speculums Medical probes Needle sheaths Single-use exam devices Device housings Handheld device components Caps, plugs & closures Equipment knobs & guards Custom parts to your drawing
See Full Capabilities →

Certifications & Compliance

Documentation That Holds Up in Your Audit

How Medical Customers Qualify Us

Our production runs under ISO 9001:2015 certified quality management, with every medical batch molded in named resin grades and traced by lot. Medical customers qualify us the thorough way: material documentation, batch records, first article reports, and their own supplier audits, which we welcome. Tell us your device classification and target market, and we'll confirm what we can support before you commit to tooling.

Material Traceability

Named resin grades, lot-traced per batch, certificate of analysis available.

FDA / RoHS / REACH Statements

Material-level compliance statements on request, to support your filings and customs.

FAI on Every New Mold

First article inspection report before any production batch ships.

Customer Stories

Medical Programs That Never Left

Quality promises are easy to make. Here is what it looks like when a medical buyer stays for decades.

Family of medical gas regulator handwheels from 26mm to 66mm
Medical Gas OEM17 Years

17 Years: From One Handwheel to a Full Series

Seventeen years ago, a European medical gas OEM trusted us with a single regulator handwheel. We held the bore at ±0.05 mm, matched five different materials to the torque each valve needs, and over the years we have built molds for more than 40 variants. The orders have continued ever since.

40+
Handwheel SKUs
±0.05
mm bore tolerance
5
Materials matched to torque
Read the Full Story →
Green dental impression trays, injection molded since 1996

One Impression Tray, 30 Years of Repeat Orders

Molded since 1996, with 99%+ first-pass yield and no returned batches on record.

→ Assembled medical gas flowmeter with graduated tube

Every Flowmeter Calibrated Before It Ships

Molded, assembled, and each unit tested on a standard gas source to ±4% FS accuracy.

→
More Case Studies →
Have a Medical Part to Mold?

Send a drawing, a 3D file, or a sample, under NDA if you prefer. You'll get a quote and free DFM feedback within three business days, along with an honest answer on whether we're the right fit.

Request a Quote → All Industries →

Contact

FAQ

What quality documentation comes with a medical order?
Production runs under ISO 9001:2015 certified quality management. Your order can include a first article inspection report, per-batch material traceability with certificates of analysis, and the dimensional records for every batch. When your auditor asks, the answer is a record we already keep rather than one written after the question.
Can you provide FDA-listed or biocompatible material statements?
At the material level, yes. We mold named, traceable grades of GPPS, PC, LDPE and other resins, and we provide the resin producer's FDA, RoHS, and REACH statements on request. Tell us the standard your device must meet, and we'll confirm grade availability before we quote.
Our device isn't launched yet. Will you sign an NDA?
Yes, before you send a single file. We don't publish customer names, and most of what we mold ships under our customers' own brands, so discretion is part of how we work.
What volumes make sense for a medical part?
Injection molding pays off when volumes are steady, typically tens of thousands of pieces a year and up. Multi-cavity tooling brings the unit cost down further; our needle sheath, for example, molds ten pieces every shot on a 10-cavity tool. Send your annual quantity and we'll recommend a cavity count and show you the math.
Can our quality team audit you before we commit to tooling?
We welcome it. Medical customers qualify us the thorough way: material documentation, batch records, and their own supplier audit on our floor in Ningbo. An afternoon in the factory answers questions faster than any brochure.
How do we get from drawing to approved samples?
Send a drawing, a 3D file, or a sample, under NDA if you prefer. You'll get a quote and free DFM feedback within three business days. After tooling, you receive first article samples with a full inspection report, and production starts only after you approve them.