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InfoGram

Safety Notices Posted for Certain Medical Gloves and Respirators

Posted: Nov. 4, 2021

2 notices identify potential risks to health care professionals, patients and users.

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

Medical gloves notice

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.

N95 notice

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 you are in possession of any ASG100 product in the 6 lots listed, review Advoque Safeguard's User Notice #1 PDF.

This article is based on content in the
Nov. 4, 2021 InfoGram.

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