Medical Device Seal Components | USP Class VI ISO 10993 Compliant

When patient safety and regulatory compliance are non-negotiable, Detroit Sealing Components delivers precision-engineered seal components fully compliant with USP Class VI and ISO 10993 standards. From O-rings and diaphragms to custom LSR molded parts, our biocompatible sealing solutions are manufactured to meet the exacting demands of medical device applications.

Precision medical device seal components including O-rings and diaphragms compliant with USP Class VI and ISO 10993 standards

Our Medical Device Seal Component Services

Explore our full range of biocompatible, USP Class VI and ISO 10993 compliant sealing solutions engineered for medical device applications.

Medical Seals

Purpose-built sealing components designed for medical device applications, manufactured from biocompatible materials to meet USP Class VI and ISO 10993 compliance requirements for patient safety.

LSR Products

High-purity Liquid Silicone Rubber components manufactured in a Class 1000 cleanroom with automated, closed-loop processing to ensure maximum biocompatibility and consistent quality for medical and pharmaceutical use.

Medical-Grade O-Rings

Standard and custom O-rings available in biocompatible elastomeric materials across a broad size range, designed for reliable sealing in healthcare, pharmaceutical, and medical device assemblies.

Diaphragms

Precision-molded diaphragms in medical-grade materials including virgin rubber and silicone formulations, engineered for pumps, valves, and actuators used in medical and pharmaceutical equipment.

Gaskets & Packings

Medical-grade gaskets and packings manufactured via compression, transfer, and injection molding, with custom geometries and material selection tailored to healthcare and device assembly requirements.

Custom Solutions

Bespoke sealing components developed using CAD and finite element analysis, with access to hundreds of biocompatible compounds and ISO 17025 accredited lab testing for full regulatory compliance.

Compliance-Ready Components

Biocompatible Sealing Solutions Built for Medical Standards

Medical device manufacturers require seal components that meet the most rigorous biocompatibility and safety standards. At Detroit Sealing Components, every medical seal we supply is engineered to satisfy USP Class VI and ISO 10993 requirements—critical benchmarks for materials used in devices that contact patients or pharmaceuticals. With our ISO 17025 accredited lab, cleanroom LSR manufacturing, and access to hundreds of validated compounds, we partner with medical OEMs across the country to deliver sealing solutions that are reliable, traceable, and fully compliant.

Medical-grade silicone seal components and O-rings in a cleanroom manufacturing environment
Proven Industry Trust

Trusted by Medical OEMs

See how Detroit Sealing Components has helped medical device manufacturers achieve compliance and performance with precision sealing solutions.

"DSC's Medical Seals exceeded our ISO 10993 compliance requirements. Their LSR Products manufacturing in Class 1000 cleanroom ensures biocompatibility and purity our devices demand."

Dr. Sarah Chen

"We needed urgent O-Rings meeting USP Class VI standards. DSC delivered within 48 hours without compromising quality. Their responsiveness solved our production bottleneck completely."

James Mitchell

"For medical device seals, DSC's custom molding capabilities transformed our product design. Their finite element analysis and CAD expertise delivered seals perfectly engineered for our application."

Patricia Rodriguez

"DSC's grommets and washers proved invaluable for our sterile assembly processes. Their precision manufacturing and material certifications eliminated quality concerns in regulated production."

Michael Thompson

"Their custom material development service and ISO 17025 accredited lab testing gave us confidence in sourcing cost-effective medical device seals meeting all regulatory specifications."

Linda García

"We've partnered with DSC for five years. Their reliability sourcing medical device seals and custom solutions has become fundamental to our supply chain stability and growth."

Robert Patel

"Their TPE & TPU Seals with biocompatible formulations are ideal for implantable applications. The automated LSR production process guarantees consistency we need for patient safety."

Dr. Elizabeth Murphy

"As a competitor in medical device seals, DSC's market positioning with custom ISO 10993 compliant solutions and decades of precision rubber expertise is exceptional."

David Harrison

"DSC's Medical Seals exceeded our ISO 10993 compliance requirements. Their LSR Products manufacturing in Class 1000 cleanroom ensures biocompatibility and purity our devices demand."

Dr. Sarah Chen

"We needed urgent O-Rings meeting USP Class VI standards. DSC delivered within 48 hours without compromising quality. Their responsiveness solved our production bottleneck completely."

James Mitchell

"For medical device seals, DSC's custom molding capabilities transformed our product design. Their finite element analysis and CAD expertise delivered seals perfectly engineered for our application."

Patricia Rodriguez

"DSC's grommets and washers proved invaluable for our sterile assembly processes. Their precision manufacturing and material certifications eliminated quality concerns in regulated production."

Michael Thompson

"Their custom material development service and ISO 17025 accredited lab testing gave us confidence in sourcing cost-effective medical device seals meeting all regulatory specifications."

Linda García

"We've partnered with DSC for five years. Their reliability sourcing medical device seals and custom solutions has become fundamental to our supply chain stability and growth."

Robert Patel

"Their TPE & TPU Seals with biocompatible formulations are ideal for implantable applications. The automated LSR production process guarantees consistency we need for patient safety."

Dr. Elizabeth Murphy

"As a competitor in medical device seals, DSC's market positioning with custom ISO 10993 compliant solutions and decades of precision rubber expertise is exceptional."

David Harrison

"DSC's Medical Seals exceeded our ISO 10993 compliance requirements. Their LSR Products manufacturing in Class 1000 cleanroom ensures biocompatibility and purity our devices demand."

Dr. Sarah Chen

"We needed urgent O-Rings meeting USP Class VI standards. DSC delivered within 48 hours without compromising quality. Their responsiveness solved our production bottleneck completely."

James Mitchell

"For medical device seals, DSC's custom molding capabilities transformed our product design. Their finite element analysis and CAD expertise delivered seals perfectly engineered for our application."

Patricia Rodriguez

"DSC's grommets and washers proved invaluable for our sterile assembly processes. Their precision manufacturing and material certifications eliminated quality concerns in regulated production."

Michael Thompson

"Their custom material development service and ISO 17025 accredited lab testing gave us confidence in sourcing cost-effective medical device seals meeting all regulatory specifications."

Linda García

"We've partnered with DSC for five years. Their reliability sourcing medical device seals and custom solutions has become fundamental to our supply chain stability and growth."

Robert Patel

"Their TPE & TPU Seals with biocompatible formulations are ideal for implantable applications. The automated LSR production process guarantees consistency we need for patient safety."

Dr. Elizabeth Murphy

"As a competitor in medical device seals, DSC's market positioning with custom ISO 10993 compliant solutions and decades of precision rubber expertise is exceptional."

David Harrison
The DSC Difference

Why Choose Detroit Sealing Components for Medical Seals?

From cleanroom manufacturing to accredited lab testing, DSC brings specialized expertise to every medical sealing requirement.

Certified Compliance

All medical seals supplied meet USP Class VI and ISO 10993 biocompatibility standards, with full material traceability and documentation.

Cleanroom Manufacturing

LSR and high-purity components are produced in a Class 1000 cleanroom using closed-loop, automated processes for maximum product purity.

ISO 17025 Lab

Our accredited in-house lab enables custom material development and rigorous testing, supporting medical OEMs nationwide with validated compound data.

Custom Engineering

Using CAD and finite element analysis, our technical team engineers bespoke sealing solutions tailored to the unique demands of your medical device application.

Meet the DSC Team

Experienced sealing specialists dedicated to medical-grade precision and compliance.

Detroit Sealing Components (DSC), headquartered in Plymouth, MI, is a precision molded rubber goods distributor and stocking warehouse with decades of experience serving regulated industries—including healthcare and medical device manufacturing. Our skilled leadership and technical staff bring deep knowledge of biocompatible materials and compliance requirements such as USP Class VI and ISO 10993, helping medical OEMs across the United States source, develop, and qualify the right sealing components. With an ISO 17025 accredited in-house lab, cleanroom production capabilities, and partnerships with top polymer producers, DSC is uniquely positioned to support the full product lifecycle—from initial material selection through prototype testing to full production supply—always delivering with speed, reliability, and exceptional value.

Class 1000 CleanroomDedicated cleanroom manufacturing for high-purity medical LSR components
Decades of ExperiencePrecision molded rubber expertise serving medical and regulated industries
ISO 17025 Accredited LabIn-house accredited testing lab for custom compound development and validation

Frequently Asked Questions

What is an O-ring medical?

A medical O-ring is a toroidal sealing component manufactured from biocompatible elastomeric materials—such as silicone (VMQ), EPDM, or PTFE—that comply with standards like USP Class VI and ISO 10993. They are used in medical devices, drug delivery systems, surgical instruments, and pharmaceutical processing equipment to provide reliable, leak-free seals that are safe for patient and drug contact.

What gasket material is FDA approved?

What does USP class VI mean?

What is ISO 10993 compliance for medical seals?

What seal materials are available for medical device applications?

Can DSC manufacture seals in a cleanroom environment?

Do you offer custom medical seal designs?

How quickly can DSC supply medical-grade seal components?

Still Have Questions About Medical Seals?

Speak with our sealing specialists for expert guidance and a compliant solution tailored to your medical device requirements.

Certified & Trusted

Awards and Recognition

ISO 17025 accredited laboratory certification badge

ISO 17025 Accredited Lab

Internationally accredited laboratory for material testing and validation

USP Class VI biocompatibility compliance badge

USP Class VI Compliance

Sealing materials tested and verified for biocompatibility per USP standards

ISO 10993 biocompatibility standard certification badge

ISO 10993 Biocompatibility

Materials assessed to international medical device biocompatibility standards

Get Compliant Medical Seal Components—Fast

Submit your requirements below and a DSC sealing specialist will respond promptly with material recommendations, compliance documentation, and delivery options tailored to your medical device application.

Contact Us Today

For immediate assistance, feel free to give us a direct call at +1 313-887-4695 You can also send us a quick email at