Industries · Medical Device
A reference overview of biocompatible, sterilization-resistant engineering plastics for medical devices, surgical instruments, in-vitro diagnostics, drug delivery systems, and pharmaceutical packaging. Coverage spans our 5 core product lines and 14 specialty engineering grades.
Industry Overview
Reference overview of polymer selection for medical devices and pharmaceutical packaging, focused on the resin families within our published product line.
USP Class VI and ISO 10993-qualified grades of PEI, PVDF, PC, and PPS are routinely used in medical device housings, fluid-handling components, and surgical instrument handles. EVOH (ethylene-vinyl alcohol, marked as added on 2026-10-09 per verbal instruction) is the dominant oxygen-barrier layer in pharmaceutical blister and vial packaging, typically laminated with PE or PP outer layers.
Steam autoclave (121°C / 134°C), dry-heat sterilization (160°C+), gamma radiation (25–50 kGy), and ethylene oxide (EtO) are the four dominant terminal-sterilization routes for medical polymers. PPS, PEI, PVDF, and PA46 retain mechanical and dimensional properties after repeated autoclave cycles; POM and PBT are more typically specified for EtO or gamma-single-shot single-use devices.
For prefilled syringes, auto-injectors, insulin pens, and dry-powder inhalers, COC (cyclic olefin copolymer) and COP-class materials provide glass-like clarity with low protein adsorption and low extractables. PA12 and POM serve in flexible tubing, valve bodies, and metered-dose components where low friction and chemical resistance matter.
Jinsutong supplies reference grade data on the published 5 core + 14 specialty product lines for medical-device and pharmaceutical-packaging buyers. We do not provide regulatory filing, Drug Master File cross-reference, or finished-device testing. EVOH grade options for medical packaging are listed under EAA/EMAA/EVA/EVOH/PPS core lines and follow the same general-grade reference structure.
Recommended Grades
A selection of commonly traded grades from our 5 core lines and 14 specialty engineering grades that appear in medical-device specifications and pharmaceutical packaging data sheets. Always verify USP/ISO qualification with the original manufacturer.
| Grade | Manufacturer | Resin | Features | Typical Use |
|---|---|---|---|---|
| Ultem® HU1000Internal snapshot · original TDS on request | SABIC (PEI) | PEI (unfilled) | USP Class VI, ISO 10993, high heat | Medical device housings |
| Ultem® 2300 | SABIC (PEI) | PEI 30% GF | High stiffness + heat, biocompatible | Surgical instrument handles |
| Solef® 1010 | Solvay (PVDF) | PVDF (homopolymer) | USP Class VI, chemical resistance | Fluid handling, filters |
| Kynar® 720Internal snapshot · original TDS on request | Arkema (PVDF) | PVDF (homopolymer) | High purity, biocompatible | Pharmaceutical tubing |
| Ryton® R-4-02Original on file · not published · ask us | Solvay (PPS) | PPS (unfilled) | Steam sterilizable, 200°C+ HDT | Autoclavable device components |
| Ryton® R-7-02No vendor TDS · source on request | Solvay (PPS) | PPS (40% GF) | High stiffness, steam sterilizable | Surgical instrument frames |
| Stanyl® TW300Internal snapshot · original TDS on request | DSM (PA46) | PA46 (heat-stabilized) | High temp 285°C HDT, wear-resistant | Surgical instrument handles |
| Topas® 8007Internal snapshot · original TDS on request | TOPAS Advanced Polymers (COC) | COC | Glass-clear, low extractables, USP VI | Prefilled syringes, IVD |
| Eval® E171BNo vendor TDS · source on request | Kuraray (EVOH) | EVOH (32 mol% ethylene) | High oxygen barrier (clarified) | Pharmaceutical blister (with PE/PP) |
| Makrolon® Rx2440No vendor TDS · source on request | Covestro (PC) | PC (medical grade) | USP Class VI, gamma-stable, clear | Device housings, connectors |
For the full grade reference across 5 core lines and 14 specialty grades, see the Jinsutong grade database.
Typical Applications
Reference application overview covering surgical instruments, diagnostic equipment, drug delivery, and pharmaceutical packaging.
PEI, PA46, and PPS are typical choices for instrument handles, frames, and autoclavable components. POM and PBT serve in single-use staplers, clamps, and forceps where dimensional stability and low friction are critical. Sterilization routes: autoclave, gamma, EtO.
COC (cyclic olefin copolymer) is widely used in microfluidic cartridges, IVD wells, and prefilled diagnostic consumables because of its glass-like clarity, low autofluorescence, and chemical resistance. PC housings and PVDF fluidic fittings are common in benchtop analyzers.
Auto-injectors, insulin pens, dry-powder inhalers, and infusion pumps use POM for internal metering, PBT and PC for outer housings, and PA12 for flexible tubing and valve diaphragms. EVOH films are used in primary packaging of sensitive drug formulations.
EVOH (ethylene-vinyl alcohol, marked as added 2026-10-09 per verbal instruction) is the dominant oxygen-barrier layer in pharmaceutical blister and vial packaging, typically coextruded with PE / PP / PET outer layers. PP and PE grades from our 14 specialty lines are widely used in bottle caps, vials, and container sealing systems.
PVDF, PA12, and PPS serve in luer fittings, stopcocks, and manifold blocks. PBT and PC are used in connector housings and cable overmolds. Chemical resistance to common disinfectants (alcohol, bleach, hydrogen peroxide) is a key selection criterion.
Reusable hospital equipment housings and sterilization trays use PEI, PPS, and PBT for thermal endurance. PC (Makrolon® Rx2440 and similar) is widely used in clear instrument housings and face-shield components requiring impact resistance.
Compliance & Standards
Buyers of medical-grade polymers typically cross-reference the following standards during qualification. Always verify with the specific grade's data sheet and your regulatory affairs team.
ISO 10993 series (cytotoxicity, sensitization, irritation, systemic toxicity), USP <87> / <88> (Class VI), and FDA 21 CFR parts relevant to food / drug contact. Qualification status varies by grade, color/additive package, and processing route.
Steam autoclave (typically 121°C / 134°C), dry-heat (160°C+), gamma radiation (25–50 kGy), and ethylene oxide (EtO). Cycle count and dose tolerance must be confirmed with the manufacturer; this overview does not substitute for the official data sheet.
EU MDR 2017/745 (European Medical Device Regulation), US FDA 21 CFR (drug and device master files), China NMPA (formerly CFDA) registration, and pharmacopoeia monographs (USP, EP, JP) for pharmaceutical packaging contact materials.
Jinsutong provides grade reference data (TDS, basic regulatory statements) for the published 5 core + 14 specialty product lines. We do not provide regulatory filing services, Drug Master File cross-reference letters, or finished-device validation testing.
Why Jinsutong
A focused B2B polymer supplier for medical-device, diagnostic, and pharmaceutical-packaging procurement teams.
Our published line covers 5 core resins (EAA, EMAA, EVA, EVOH, PPS) and 14 specialty engineering grades (PA66, PPA, PA46, PA12, PVDF, PEI, LCP, PBT, PC, POM, PC+ABS, COC, ABS, PP) — the resin families that appear most often in medical-device specifications and pharmaceutical packaging data sheets, within the published scope.
A reference grade database with manufacturer, product family, grade code, reinforcement, and typical use is published on the Jinsutong grade reference page. EVOH is included as a 5th core line per verbal instruction on 2026-10-09.
All inquiries route through our business manager Mr. Mo Hailong (+86 138 1603 7020 / 13816037020@139.com / QQ 2867872247). No online order, no online pricing, no automated fulfillment — grade selection and lead time are confirmed conversation by conversation.
Jinsutong is the polymer-supply reference identity of Shanghai Jinsutong Plastics Co., Ltd. (上海金塑通塑胶有限公司), a B2B plastics trading and technical-service company. We sit between the global resin manufacturer and the China-region medical / industrial / electronics buyer.
If you are evaluating a specific resin / grade for a medical device, diagnostic consumable, or pharmaceutical packaging application, send us the application brief (sterilization route, regulatory class, expected volumes) and we will pull a reference grade list from our 5 + 14 published product line. For regulatory filing, Drug Master File cross-reference, or finished-device testing, please work directly with the resin manufacturer.
Reference overview only. Biocompatibility and regulatory compliance depend on the specific grade, color/additive package, and processing route. Always confirm with the original manufacturer data sheet and your regulatory affairs team before medical-device filing.