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.
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FDA Investigating Disposable Gloves From Hundreds Of Foreign Companies Because Of Reprocessing Fears
The US FDA says it’s “investigating certain imported medical gloves that appear to have been reprocessed, cleaned, or recycled and sold as new.” The 270 firms in question are listed on an import alert that says their gloves are subject to Detention without Physical Examination.
Invacare, Smiths Medical and CellEra were cited for quality systems and Medical Device Reporting violations in the only device-related warning letters released by the agency last month.
Manufacturers can’t use the US FDA’s voluntary eSTAR product submission program for de novo requests until January – but they can start practicing now on how to use eSTAR for that review pathway.