Dangerous Medical Gloves: Here Are The 270 Companies On Import Alert

Here’s the complete list of foreign firms that were included on an import alert because gloves they made or sold may have been “reprocessed, cleaned, or recycled and sold as new,” the US FDA says.

Large amount of white latex gloves background surface.
• Source: Alamy

Below is a complete list of 270 companies from 16 countries that were included on a 26 October import alert that says medical gloves from the firms are subject to Detention without Physical Examination because they may have been reprocessed, cleaned, or recycled and sold as new. (See main story, “FDA Investigating Disposable Gloves From Hundreds Of Companies Because Of Reprocessing Fears,” for more details.)

[Editor’s note: Company names were taken directly from “Import Alert 80-04: Surveillance and Detention Without Physical Examination of Surgeon’s...

Medtech Insight Podcast

Keep up with the top medtech business and regulatory news.

Medtech Insight brings you interviews and analysis, on the go.

More from Regulation

Digital Health Roundup: Digital Therapeutics Navigate GLP-1, Immersive Gaming; DHCoE AI Framework; Hello Heart

In this week’s Digital Health Roundup, Medtech Insight’s Ryan Nelson highlights Click Therapeutics’ FDA-cleared digital therapeutics (DTx) for depression and Sinaptica Therapeutics’ personalized neuromodulation for Alzheimer’s patients. Marion Webb discusses her interview with MindMaze’s John Krakauer on their gaming-focused DTx to help people recover from serious brain injuries. Elizabeth Orr introduces new voting members of the new Digital Health Advisory Committee and Natasha Barrow discusses Hello Heart’s new symptom-tracking feature in their heart-focused app.

News We’re Watching: New FDA Approvals For Breast Implant, Colon Cancer Test, Imaging Agent; TAP Expansion, AI Standards

This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.  

MI-PolicyAndRegulation (Free-1): Biliary Atresia Linked to Autism and Neurodevelopment Delays

 
• By 

Children with biliary atresia (BA) exhibited neurodevelopmental deficits and increased autism traits, with earlier surgery linked to better general neurodevelopment.

Global Medtech Guidance Tracker: September 2024

 
• By 

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

More from Policy & Regulation

News We’re Watching: New FDA Approvals For Breast Implant, Colon Cancer Test, Imaging Agent; TAP Expansion, AI Standards

This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.  

MI-PolicyAndRegulation (Free-1): Biliary Atresia Linked to Autism and Neurodevelopment Delays

 
• By 

Children with biliary atresia (BA) exhibited neurodevelopmental deficits and increased autism traits, with earlier surgery linked to better general neurodevelopment.

Sponsored By

Nancy Tests SPARC-931 Part 7

This is a description