We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Stryker’s N95 Mask Decontaminator Gets Emergency Use Authorization

Stryker’s N95 Mask Decontaminator Gets Emergency Use Authorization

Respirator COVID-19 Patient doctor protection
June 2, 2020

The FDA has issued an Emergency Use Authorization (EUA) for Stryker Sustainability Solutions’ decontamination system for N95 respirators, allowing its use by healthcare staff.

The self-contained system, which has not been granted clearance for any uses in the past, can now be used by healthcare workers to decontaminate compatible N95 respirators for reuse by multiple users.

The Stryker system, which uses vaporized hydrogen peroxide, is not authorized for use with N95 respirators containing cellulose-based materials, the agency said.

View today's stories

Medical Devices COVID-19 Submissions and Approvals

Upcoming Events

  • 24May

    Powering an Effective Oversight Strategy with Clinical and Operational Insights

  • 25May

    2022 WCG Avoca Quality & Innovation Summit: Own the Future

  • 21Jun

    Medical Device Reporting: Best Practices and Common Pitfalls

  • 22Jun

    Meet CDRH’s New Strategic Priorities: Where the Center is Headed and How Devicemakers Can Keep Up

  • 28Jun

    Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • Accelus FlareHawk Interbody Fusion System Cleared

  • Use of Pfizer’s Paxlovid Spikes by 315 Percent

  • Linear Health Sciences Gets FDA Clearance for Its Orchid Safety Release Valve

  • Roche’s Faricimab Gains UK Approval Via International Program

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing