TAIPEI, November 4, 2022 – Medtecs International Corporation Limited (Medtecs) proudly announced that on October 21, two of the company’s sought-after disposable gowns, CoverU Disposable Gowns with Tape AAMI Level 4 Isolation Gown and CoverU Disposable Gown with Tape – Chemo Gown have received 510(k) clearance from the U.S. Food and Drug Administration (FDA), affirming the safety and effectiveness of Medtecs’ products.
The results came after a rigorous process to review the gowns’ performance data and ensure that both meet all the requirements of the FDA. This marked another significant milestone for the world’s leading personal protective equipment (PPE) brand as it expands its presence in the United States with the best protective solutions available. It is also the first time a PPE brand from Taiwan acquired clearance on isolation and chemo gowns at the highest protection level in the United States.
Unlike traditional surgical gowns, ANSI/AAMI PB70 Level 4 isolation gowns need to offer larger critical zones. The seams and attachment areas of these Medtecs products meet the highest AAMI Level 4 standards and are further reinforced to provide healthcare professionals with all-around protection.
Furthermore, all non-sterile isolation gowns that claim to meet ANSI/AAMI PB70 Level 4 protection level are required to submit a 510(k) premarket notification to the FDA to demonstrate that the products are safe and effective before entering the local market. However, so far only five isolation gowns meeting AAMI Level 4, including Medtecs’ own CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown and CoverU Disposable Gown with Tape – Chemo Gown, are registered in the FDA 510(k) database. This means many of the isolation gowns that claim to have met AAMI Level 4 protection out on the market are without FDA’s clearance.
According to ERIC Institute, an independent healthcare organization, “more than half of the disposable isolation gowns with unstated levels of protection” failed to even meet the lowest AAMI level of protection, potentially exposing healthcare professionals to dangerous viruses, bloodborne pathogens and other harmful microorganisms.
The FDA 510(k) clearance will ensure that the healthcare community has access to safer and more effective disposable isolation gowns, which is in line with Medtecs’ mission to provide safe and effective products with speed, warmth, and care.
These disposable gowns are the latest in Medtecs’ portfolio following Medtecs’ receipt of FDA 510(k) clearance for its surgical mask. Looking ahead, Medtecs will continue to uphold all its products’ levels of quality and performance, and seek to deliver more top-of-the-line PPE to cover all protection needs.
Product Details:
- CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown
Intended to provide barrier protection and protect healthcare personnel and patients from the transfer of microorganisms, body fluids and particulate materials. The isolation gown meets the requirements of the highest AAMI Level 4 barrier protection for an isolation gown for use in health care facilities.
- CoverU Disposable Gown with Tape – Chemo Gown
Similar to the isolation gown, the chemo gown also meets AAMI Level 4 protection and is designed to provide barrier protection against fluids and other harmful microorganisms. Unlike the isolation gown, however, the chemo gown is specifically designed for use during chemotherapy.
For more information on the two gowns, please visit:
- CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown
- CoverU Disposable Gown with Tape – Chemo Gown
Press Contact
Marketing Team
pr@medtecs.com
