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Healthcare Silicone LSR

Custom LSR Protective Sleeve for Medical Device

Industry: Healthcare / Medical Device
Material: USP Class VI Liquid Silicone (LSR)
Standard: FDA 21 CFR / USP Class VI

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Custom LSR Protective Sleeve for Medical Device

Challenge · Solution · Result

CHALLENGE

Medical device OEM required a transparent LSR sleeve with wall thickness 0.4–0.6mm, zero visible parting lines, and USP Class VI biocompatibility for a handheld diagnostic probe.

OUR SOLUTION

Selected Platinum-cured 30A LSR with high optical clarity. Engineered cold-runner 4-cavity mold with vacuum-assisted injection to eliminate short shots at 0.4mm wall section.

RESULT

Wall thickness consistency ±0.03mm. Zero visible parting flash. Passed USP Class VI and cytotoxicity testing. 2M units delivered with 0 customer quality complaints.

Engineering Insights

DFM Analysis

DFM Analysis & Process Optimization

DFM Analysis: Cold runner system eliminated waste — 100% material utilization. Wall-thinning risk zones pre-validated via Moldflow shrinkage simulation.

Our engineers work from your CAD drawings before any tooling begins — identifying potential failure modes, proposing material alternatives, and validating gate/cooling layouts digitally. This eliminates costly mold revision cycles.

Empirical Test Data

Physical test results from production samples — available with every shipment on request.

Property Requirement Result
Wall Thickness Range 0.4–0.6 mm 0.42–0.58 mm
Shore Hardness 30A ± 3 30A ± 2
Biocompatibility USP Class VI PASS
Tensile Strength ≥ 6 MPa 7.2 MPa

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Share your drawings, quantity and material requirements. Our team performs a complimentary DFM review before quoting.

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