Custom CGM Introducer Needles & Sensor Insertion Tubing
Precision 28G (0.36 mm OD) to Custom Specifications | ISO 13485 Certified OEM/ODM Manufacturing
Product
Advantages
Optimal 28G (0.36 mm OD) Benchmark
Engineered to a minimum outer diameter of 0.36 mm (28G), providing the ideal balance of structural column strength to prevent buckling while minimizing skin insertion resistance.
Low-Trauma & Non-Bleeding Design
Optimized needle tip geometries significantly reduce tissue damage and localized bleeding during penetration, enhancing overall patient comfort and sensor wearable experience.
Biocompatible & Medical-Grade Cleanliness
Processed under strict ISO 13485 quality standards, all components undergo specialized non-residue cleaning to ensure oil-free, contaminant-free surfaces.
Fully Scalable Dimensions
From ultra-thin 0.36 mm OD tubing to large custom configurations, we accommodate diverse wearable architectures and multi-sensor insertion devices.
Process & Manufacturing Excellence
Proprietary Micro-Edge Bevel Grinding
Custom primary and secondary bevel angles optimized for minimal puncture force. Micro-smooth bevel edge to prevent skin tearing and reduce localized trauma/bleeding during penetration.
Burr-Free Micro-Laser Slotting
High-precision side slots, notches, and retention windows for secure sensor alignment. Integrated electro-polishing to ensure zero internal/external micro-burrs, protecting fragile sensor coatings. Supports round/oval/square shapes.
Tight Tolerance & High Cpk Quality Control
Critical dimensions are controlled to Cpk ≧1.33 under ASME Y14.5 standards, ensuring 100% batch-to-batch consistency for high-speed automated assembly lines.
7–15 Day Rapid R&D Prototyping
Custom prototype samples delivered in 7 – 14 Business Days. Engineering assistance on bevel angle selection, wall thickness optimization, and column strength calculation. All drawings and CAD files reviewed under strict Mutual Non-Disclosure Agreement (MNDA).
Engineering Specification
| Materials | SS304/SS316L |
| OD | 28G(0.36mm)-Custom maximum |
| Wall Thickness | Custom / Ultra-Thin Wall Options |
| Tolerance | ±0.02mm |
| Column Strength & Buckling Resistance | Precision cold-drawn stainless steel (SS304/SS316L) with optimized temper (Full Hard / Extra Hard) |
| Peak Insertion Force Optimization | Custom primary/secondary bevel grinding engineered to reduce peak tissue resistance |
| Smooth Retraction Mechanics | Controlled ID surface finish and burr-free notch edges |
| Micro-Bevel Geometry | Multi-bevel options (Lancet, Tri-bevel, or Custom 3D bevels) |
| Critical Length Tolerance | Overall length and bevel length controlled to ±0.01mm (Cpk≧ 1.33) |
| Burr-Free Laser Slotting | Precision laser-cut side slots, retention notches, and windows; 100% electro-polished |
| Surface Roughness | Outer surface roughness Ra ≦0.2μm |
| Particulate & Non-Residue Cleaning | Multi-stage ultrasonic cleaning using validated medical-grade solvent/water processes |
| Quality Inspection Standards | Specification: 100% optical dimensional inspection; compliant with ISO 13485, ASTM, and ASME Y14.5 standards |