At Andrews Powder Coating, Inc., we prioritize quality and regulatory compliance in our coating solutions, ensuring that our products meet the highest standards for safety and performance. As an ISO 9001:2015 registered facility (Certificate Number C5553581), we offer many coatings that are being used for medical devices that our customers have tested. These materials are acceptable for ISO 13485:2003, ISO 10993-1, and FDA 510(k) standards.
Specialty Coatings & Integrated Metal Refinishing
Our coatings offer chemical, thermal, and electrical resistance. We provide custom masking solutions, as well as a single source for multi stage metal refinishing (plating, powder coating, etc).
FDA Approved Coatings
FDA compliant coatings have been used and certified for intra-body bio compatibility testing by our clients. Bio compatibility for FDA and ISO approvals must be accomplished through third party testing of the assembled medical device and submitted to the FDA for approval. No powder coating offered by Andrews Powder Coating Inc. comes with a blanket certification.
Antimicrobial Coatings
For medical, institutional, and public transportation Andrews Powder Coating Inc. offers a full line of antimicrobial coatings. Please contact us for additional information.
Specialty coatings available for the following applications:
Electrical Resistance
Chemical Resistance
Thermal Resistance
Antimicrobial
ISO 13485:2003
ISO 10993-1
Your Coating Partner: Get in Touch
Discover how our team can help you find the perfect medical-grade coating solution for your device.
Contact us below for a free quote and to learn more about our FDA-approved coatings.
FAQ About Our Medical Device Coating Service
To help you plan your medical device project, we’ve compiled a list of frequently asked questions regarding our coating expertise and services.
How do your ISO 9001-2015 certifications relate to my device's FDA requirements?
Our ISO 9001-2015 certification ensures that Andrews Powder Coating, Inc. delivers FDA-compliant coatings with the quality, consistency, and documentation needed to meet your device’s FDA requirements. We work within your ISO 13485 QMS mandates.
Whether your device involves food-contact surfaces or medical applications, our certified processes help you navigate FDA regulations confidently. To start the process, please contact us with details about your device and specific FDA requirements.
Have your coatings already been tested for biocompatibility (e.g., ISO 10993)?
At Andrews Powder Coating Inc., we understand the importance of biocompatibility for coatings used in medical device applications. The specification and use of proper FDA compliant coatings ensures the coated components of the device are in compliance under your ISO 13485 certification process requirements. This aligns with your stringent quality and regulatory standards as required for medical device coatings.
Many of our coatings, particularly those intended for medical devices (Class I, II, or III), have been tested for biocompatibility by our clients, to perform in accordance with ISO 10993 standards. This standard evaluates the biological safety of materials in contact with the body. These rigorous tests assess factors such as cytotoxicity, sensitization, irritation, and, where applicable, systemic toxicity or implantation effects, depending on the coating’s intended use and duration of contact.
Are your specialty coatings, such as antimicrobial, electrically insulative considered FDA compliant?
Andrews Powder Coating, Inc. is committed to providing specialty coatings, including antimicrobial, thermally stable and very unique electrically insulative/resistant options. These coatings meet the needs of medical, food-grade, and food-contact applications. Many of our specialty coatings are FDA compliant, meaning they adhere to relevant FDA regulations, such as 21 CFR 175.300 for food-contact surfaces or Current Good Manufacturing Practices (cGMP) for medical device coatings, without requiring premarket approval.
How can antimicrobial coatings benefit my medical or commercial device?
Our antimicrobial coatings are designed to inhibit microbial growth, making them ideal for medical devices (e.g., Class I or II tools) or food processing equipment. These coatings are formulated with FDA-compliant ingredients, ensuring they meet safety standards for their intended use, such as preventing contamination in food-contact environments, or maintaining hygiene on medical surfaces. Many of these powder coatings have been tested for biocompatibility per ISO 10993 when applicable. Years of applications used in real world medical theatres, have confirmed and proven powder coatings’ durability and safety for medical applications.