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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device decontamination kit
Definition This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeMAC
Regulation Number 878.4014
Device Class 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 1 1
2023 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 7 7
Device Slipped 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
Headache 1 1
Hypersensitivity/Allergic reaction 1 1
Rash 1 1
Vomiting 1 1
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Emergent Protective Products USA Inc I Jan-10-2023
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