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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device non-niosh-approved disposable filtering facepiece respirators (ffrs)
Definition For use in healthcare settings by healthcare personnel when used in accordance with CDC recommendations to prevent wearer exposure to pathogenic biological airborne particulates during FFR shortages resulting from the COVID-19 outbreak (see: https://www.fda.gov/media/136403/download) (also see: https://www.fda.gov/media/136664/download). *This excludes NIOSH-approved respirators that are under EUA *This includes authorized KN95s from China under EUA *This excludes KN95s imported under enforcement discretion that don’t have EUA *This includes all authorized non-NIOSH-approved FFRs under EUA
Product CodeQKU
Device Class Not Classified

MDR Year MDR Reports MDR Events
2021 1 1
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Product Quality Problem 2 2
Packaging Problem 1 1
Material Fragmentation 1 1
Device Emits Odor 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 1 1
Insufficient Information 1 1
Choking 1 1
Cough 1 1

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