Medical Die Cutting & FDA Materials

Die Cut Technologies has met precise OEM requirements for medical and approved FDA applications utilizing a variety of methods to die-cut shapes, slit, and laminate for customers in the medical, sanitary, and FDA markets for decades. We provide custom cut parts for precise applications in medical devices, water purification, and food processing.

Our converting capabilities also include digital die-less cutting and Class 100000 cleanroom die-cutting. As a leading medical and FDA material converter, we have the knowledge and expertise required to select, design, and develop approved and certified materials meeting the most stringent requirements.

Below are the most common types and definitions we use to help select the correct material for your project

FDA Compliant Silicone Rubber

"FDA Grade" silicone rubber is commonly used in applications where food and pharmaceuticals are present. This material is low volatile, peroxide-free, and does not discolor over time. FDA ingredients are used to make this product and are listed in CFR 177.2600. This material is ozone and UV resistant and is an excellent gasketing material.

USP Class IV Classification

Medical devices need materials that are safe for direct or indirect patient contact. DCT uses FDA USP Class IV silicone that meets the most stringent requirements for biocompatibility and has received a certificate of compliance from a leading laboratory. 

NSF 61 approved CERTIFIED NSF / ANSI 61-G & 372 | NSF-61 EPDM Rubber 

Suitable for use in potable water applications. This specification-grade NSF / ANSI 61 ETHYLENE PROPYLENE DIENE (EPDM) meets American Water Works Association (AWWA) Standard C111/A21.11 for clean and safe drinking water and wastewater purposes. NSF is accredited by the National Plumbing Code, U.S. Model Codes, and the Uniform Plumbing Code (UPC).

NITRILE - White Food Grade / FDA Compliant 

Nitrile rubber (Butadiene Acrylonitrile (NBR)) is recommended in all phases of food processing and manufacturing of pharmaceuticals and cosmetics. Excellent oil resistance and temperature range. Non-toxic, non-allergenic materials. Long life, repeated temperature cycling. Non-marking.

PTFE (Teflon®) 

Polytetrafluoroethylene (PTFE) is DuPont's trademark of Teflon®. Teflon (PTFE) conforms to both FDA and AMS specifications, making it acceptable to both medical and food production industries. The three basic types of PTFE (Teflon®) materials include Virgin Teflon®, Filled Teflon®, and Expanded Teflon®.

Silicone Gaskets

DCT manufactures products made from a platinum-cured silicone that meets requirements from both the U.S. Pharmacopeia (USP) and the Food and Drug Administration (FDA). These materials are safe for gamma sterilization and won’t leach extractable at elevated temperatures. Applications include medical devices and components. Because silicone is odorless and tasteless, it is ideal for certain surgical and food processing applications

FDA Approved Materials for Medical Devices

Die Cut Technologies provides FDA USP Class VI materials in making medical die-cut seals, gaskets, and washers. Examples include sanitary or hygienic gaskets for medical devices, and enclosure gaskets, and housing gaskets for medical equipment. These silicones are also used in medical wearables and diagnostics. In addition, to die-cutting, DCT provides laser cut and other gasket fabrication processes. 

From concept to completion, Die Cut Technologies provides solutions for all your converted materials and custom fabricated parts in the medical, FDA, and filtration markets. Contact us now for a prompt quote.

Medical Grade Silicone Part

FDA Logo


USP Class



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