PM27S01N: Polyplastics’ High‑Flow POM for Advanced Medical Devices

Polyplastics Group, headquartered in Japan with a U.S. office in Farmington Hills, Michigan, has launched PM27S01N—a high‑flow polyoxymethylene (POM) grade engineered for drug‑contact and delivery applications. The material’s exceptional flow properties enable reduced wall thickness, device miniaturization, and lower weight, addressing the demands of increasingly sophisticated medical devices.

PM27S01N meets the strictest global regulatory requirements for medical and food contact, including ISO 10993, USP Class VI biocompatibility/cytotoxicity, FDA Drug Master File (DMF) and Device Master File (MAF), EU 10/2011, and FDA food‑contact 21 CFR 177.2470. This compliance assures manufacturers that the material can be seamlessly integrated into regulated products.

The material is produced under a robust quality framework that follows VDI 2017 medical‑grade plastics guidelines, VDI standard quality management, and GMP‑based production management. Full traceability from raw material to final product ensures consistent performance and compliance across the supply chain.

Polyplastics’ Duracon PM series, which includes the workhorse grade PM09S01N, complements its Topas cyclic olefin copolymer (COC) line—both high‑purity options tailored for medical applications. Manufacturers can access extensive long‑term reliability data and request customized testing reports covering extraction, moldability, durability, slip, and wear characteristics.

With PM27S01N, Polyplastics continues to provide medical device manufacturers with reliable, compliant, and high‑performance materials that support innovation in drug delivery and beyond.