USFA Discusses Safety Notices Posted For Certain Medical Gloves And Respirators

Notices were recently posted by the Food and Drug Administration (FDA), the National Institute for Occupational Safety and Health (NIOSH), and the National Personal Protective Technology Library (NPPTL) concerning the safety and quality of 2 types of personal protective equipment (PPE) used frequently by emergency medical services personnel: medical gloves and N95 particulate filtering facepiece respirators.

Medical gloves notice

Medical gloves notice is issued by the FDA on Oct. 29, 2021. This notice concerns the FDA’s investigation of certain imported medical gloves that appear to have been reprocessed, cleaned or recycled and sold as new and are not adequate quality for distribution in the United States.

The FDA is recommending that health care facilities and providers do not purchase or use imported medical gloves from companies included on the FDA's Import Alert 80-04: Surveillance and Detention Without Physical Examination of Surgeon's and Patient Examination Gloves.

To identify FDA-cleared medical gloves, search the FDA's 510(k) Premarket Notification database using the product codes for medical gloves.

N95 notice

N95 notice is issued by NIOSH NPPTL on Sept. 17, 2021. This notice concerns some of Advoque Safeguard’s NIOSH-approved N95 particulate filtering respirators.

The notice lists 6 lots of model ASG100 N95 Particulate Filtering Respirator (TC-84A-9284) requiring additional sampling for pressure testing: 44226-2, 44228-2, 44247-3, 44260-3, 44261-3 and 44249-3.

For full details, including what to do if one is in possession of any ASG100 product in the 6 lots listed, one can review Advoque Safeguard's User Notice #1 PDF.