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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device medical gloves with chemotherapy labeling claims - test for use with chemotherapy drugs
Definition A disposable medical glove (examination or surgeons) that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves have been tested for permeation and breakthrough resistance against various concentrations and types of chemotherapy drugs using test such as astm d6978-05, standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs.
Product CodeOPJ
Regulation Number 880.6250
Device Class 1

MDR Year MDR Reports MDR Events
2020 9 9
2021 6 6
2022 3 3
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 11 11
Defective Device 5 5
Physical Resistance/Sticking 3 3
Device Damaged Prior to Use 2 2
Material Puncture/Hole 2 2
Product Quality Problem 1 1
Material Discolored 1 1
Melted 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Contamination with Chemical or Other Material 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 8 8
No Clinical Signs, Symptoms or Conditions 7 7
Insufficient Information 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Patient Involvement 1 1

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