Sterile Cleanroom Solutions for Reliable Medical Product Creation

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Sterile Cleanroom Solutions for Reliable Medical Product Creation

Customization:	Available
Type:	Medical
Material:	Medical Grade ABS, PC, Silicone, TPU

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Product Description

Overview - Basic Info

Model NO.

SH-medical-023

Sterilization

Without Ethylene Oxide Sterilization

Guarantee Period

Two Years

Group

Adult

Processing Method

Injection Molding, Insert Molding

Tolerance

±0.005mm

Lead Time

4-8 Weeks

Transport Package

PE Bag

Specification

PEEK plastic injection

Origin

China

Product Description

Manufacturing Expertise
Our facility has been manufacturing precision medical device components since 1987, specializing in surgical equipment manufacturing with ISO 13485:2016 certification and over 35 years of medical device expertise. Our facility features advanced CNC machining centers and precision injection molding equipment capable of producing ultra-precise gear components for critical surgical applications. Operations are conducted under strict quality management systems with comprehensive risk management, design controls, and biocompatibility validation protocols.

Product Specific Details
Our surgical equipment gear components are manufactured using medical-grade materials with exceptional precision, durability, and biocompatibility for critical surgical instrument applications. Advanced machining and molding techniques achieve tight tolerances essential for smooth operation and reliable performance in surgical environments. Specialized features include precision gear teeth, integrated assembly features, and biocompatible surface treatments. Applications include surgical power tools, robotic surgical systems, motorized surgical instruments, and precision positioning mechanisms.

Detailed Photos

Product Parameters

Product Name	Material	Processing Method	Tolerance	Certification	Applications	Lead Time	MOQ
Surgery Equipment Gear Parts	Medical Grade PEEK, POM, PA, Stainless Steel 316L	CNC Machining, Precision Injection Molding	±0.005mm	ISO 13485:2016	Surgical Power Tools, Robotic Surgery	4-8 weeks	1000 Pieces
Surgery Disposable Parts	Medical Grade PP, PE, PS, PVC, TPU	Cleanroom Injection Molding	±0.02mm	ISO 13485:2016	Surgical Drapes, Disposable Instruments	2-6 weeks	1000 Pieces
Eye Pressure Device Components	Optical PMMA, PC, COC, Stainless Steel	Precision Injection Molding	±0.002mm	ISO 13485:2016	Tonometers, Ophthalmic Diagnostics	4-8 weeks	1000 Pieces
Liquid Silicone O-Ring	Medical Grade Liquid Silicone (LSR)	LSR Injection Molding	±0.05mm	ISO 13485:2016	Cardiac Implants, Orthopedic Devices	4-8 weeks	1000 Pieces
PEEK Medical Plastic Parts	Medical Grade PEEK (450G, 450CA30)	CNC Machining, Injection Molding	±0.005mm	ISO 13485:2016	Spinal Implants, Surgical Instruments	4-8 weeks	1000 Pieces

Manufacturing Facilities

Frequently Asked Questions

What manufacturing services do you provide?

We offer comprehensive manufacturing services including precision tooling, plastic injection molding, machining parts, product assembly, In-Mold Labeling (IML), surface treatment, and complete project management from design to delivery.

What certifications does your facility hold?

We are certified to ISO 9001:2015, IATF 16949:2016, and ISO 13485:2016 standards, ensuring the highest quality for automotive, medical, and general manufacturing applications.

What is your tooling precision capability?

Our tooling division achieves 0.01mm accuracy using five-axis CNC machining centers and Moore Jig Grinding Machines with 2μm precision. We use high-end positioning systems ensuring tolerances no greater than 2μm.

What materials can you work with for medical components?

We work with a wide range of plastics including ABS, PC, PA, POM, TPU, as well as engineering plastics such as PESU, COC, PEEK, PCTG and various medical-grade materials.

How do you ensure consistent quality in production?

We use Full Automatic CMM measurement systems, RFID tracking throughout production, and all servo motor injection machines for stable quality. Over 99% of our injection machines are imported from Japan.

What is the standard lead time for tooling development?

Tooling development typically takes 4-8 weeks depending on complexity. Simple molds take about 4-5 weeks, while complex multi-cavity molds require 6-8 weeks.