ReadiMask Determined MR Safe: Patients Can Keep Respiratory Protection On During MRI Exams

Independent evaluation by MED Institute under ASTM F2503-26 gives patients and imaging facilities the documentation they’ve been asking for

SEA GIRT, NJ, UNITED STATES, October 7, 2026 /EINPresswire.com/ — Patients who rely on a respirator for protection can now bring one into the MRI room with independent documentation in hand. Global Safety First, LLC announced today that MED Institute completed an independent technical evaluation of the ReadiMask^® Strapless Respirator under the ASTM F2503-26 framework for magnetic resonance (MR) safety labeling. MED Institute determined that the evaluated ReadiMask products meet the definition of MR Safe under ASTM F2503-26 and can be labeled MR Safe. The determination covers ReadiMask with and without its optional attached Integrated Eye Shield.

MR SAFE HAS A SPECIFIC MEANING
FDA guidance recommends the ASTM F2503 framework for MR safety labeling, including the terms MR Safe, MR Conditional and MR Unsafe. Under that framework, an MR Safe item poses no known hazards resulting from exposure to any MR environment and has no MRI-related conditions or restrictions on its use. “MR Safe” differs from informal descriptions such as “metal-free” or “MRI-friendly.”

WHY THIS MATTERS TO MRI PATIENTS
ReadiMask customers have reported successfully wearing the respirator during hundreds of MRI exams, but some have encountered questions or resistance from facilities unfamiliar with the product or without independent documentation of its MR safety status. Global Safety First commissioned MED Institute to provide patients and MRI professionals clear technical documentation of ReadiMask’s MR Safe status. In a review of publicly available U.S. product information, ReadiMask was among a relatively small number of masks and respirators with detailed MRI-specific safety documentation available for patients and professionals to review.

ONE OF TWO WINNERS OF A U.S. GOVERNMENT MASK CHALLENGE
ReadiMask^® 365 was named one of only two winners of the U.S. government’s Mask Innovation Challenge, sponsored by the Biomedical Advanced Research and Development Authority (BARDA) to help develop the next generation of public-use masks. The competition drew nearly 1,500 submissions from startups, universities and major companies.

ReadiMask was evaluated by NIOSH and NIST for filtration efficiency, breathability, comfort, fit and function, and separately by the U.S. Army for filtration efficiency and breathing resistance using NIOSH test procedures.

IT’S ALL ABOUT THE SEAL
Instead of head straps or ear loops, ReadiMask uses a medical-grade adhesive around its perimeter to seal directly to the skin, conforming to individual facial contours across a wide range of face shapes and sizes. Because the adhesive does the work, there is no metal nose wire, no staples, no clips and no fasteners. That construction is why ReadiMask is so well suited to the MR environment: consistent with its MR Safe labeling, it may be worn during MRI exams without restrictions based on scanner type or magnetic field strength.

“ReadiMask seals to the face without straps and without metallic structural components, and now an independent evaluation under ASTM F2503-26 confirms what that means in the MRI room,” said John Schwind, inventor and CEO of Global Safety First. “Patients get a respirator that fits, seals, and goes with them through the scan.”

“Clear, standardized documentation helps MRI professionals make informed decisions about products entering the MR environment. We were pleased to evaluate ReadiMask under ASTM F2503-26 and provide objective technical support for its MR Safe labeling, helping provide patients with access to this innovative respiratory protection during MRI,” said David Gross, PhD, PE, Vice President of MED Institute.

FOR MRI FACILITIES
MRI technologists, MR Safety Officers and procurement staff can review the complete MED Institute technical memorandum and the one-page MR Safe determination at ReadiMask.com/MRI.

ABOUT READIMASK
ReadiMask is a strapless filtering facepiece respirator developed by Global Safety First, LLC. It uses a medical-grade adhesive around its perimeter to seal directly to the user’s face. ReadiMask is made in the USA.

ABOUT MED INSTITUTE
MED Institute is a contract research organization providing medical device testing, engineering, regulatory and clinical services, including MRI safety evaluation. MED Institute is accredited to ISO/IEC 17025:2017 and certified to ISO 13485:2016.

MRI information and technical documentation: ReadiMask.com/MRI

Media resources and high-resolution images: ReadiMask.com/MR-Safe-Media-Kit

Media inquiries: ReadiMask.com/Media-Inquiry

John A Schwind
Global Safety First

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