INDUSTRY VERTICAL

Medical Devices

FDA-compliant resins for implantable, single-use, and durable medical device applications. Documented biocompatibility, clean-room-compatible handling, and full lot traceability from pellet to finished part.

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QUICK SPEC - MEDICAL PC

BiocompatibilityISO 10993

SterilizationEtO, Gamma, Steam

Clarity>88% Transmission

HDT @ 0.45 MPa138 C

ApplicationSurgical housings

MATERIAL PORTFOLIO

Medical-Grade PC

Crystal-clear, gamma-stable, ISO 10993 compliant. Used in surgical instrument housings, IV connectors, and diagnostic device enclosures.

PETG

Gamma-Stabilized PETG

Maintains clarity post-irradiation. Preferred for single-use device packaging, sample containers, and fluid path components.

FDA-Grade PP

USP Class VI homo- and copolymer grades for syringe components, drug delivery systems, and sterile packaging.

PEEK

PEEK Engineering

Implant-grade PEEK for orthopedic, dental, and spinal applications. Radiolucent with documented biocompatibility.

PEBA

Pebax Elastomer

Flexible catheter and tubing grades. Kink-resistant, radiopaque-compatible, and available in hardnesses from 25D-72D.

TPU

Medical-Grade TPU

Ether and ester-based grades for tubing, wearable patches, and flexible enclosures. Hydrolysis-resistant options available.

TECHNICAL REQUIREMENTS WE COVER

Biocompatibility Documentation

ISO 10993-series test reports on file. Cytotoxicity, sensitization, and USP Class VI data available per lot.

Sterilization Compatibility

Grades validated for EtO, gamma (25-50 kGy), electron beam, and autoclave. Color stability and mechanical retention data provided.

Extractables and Leachables

E&L screening data for high-risk applications. Compliant with FDA guidance on extractables for container-closure systems.

Full Lot Traceability

Material genealogy from monomer source through final pellet. CoC and CoA per shipment. Archive samples available on request.

Need an FDA-compliant material?

Share your device class, sterilization method, and contact surface requirements. We match a grade and provide supporting compliance documentation.

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