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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device helmet, surgical
Regulation Description Surgical apparel.
Product CodeFXZ
Regulation Number 878.4040
Device Class 1

Device Problems
Overheating of Device 48
Smoking 3
Material Split, Cut or Torn 1
Fire 1
Temperature Problem 1
Break 1
Thermal Decomposition of Device 1
Leak / Splash 1
Fitting Problem 1
Electrical Shorting 1
Air Leak 1
Material Separation 1
Total Device Problems 61


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