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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device foam or gel chemical sterilant/high level disinfectant
Definition A foam or gel chemical sterilant/high level disinfectant is a germicide in the form of a foam or gel that is intended for use as the terminal step in high level disinfection of medical devices prior to patient use.
Product CodeQWS
Regulation Number 880.6886
Device Class 2


Premarket Reviews
ManufacturerDecision
TRISTEL SOLUTIONS , LTD.
  SUBSTANTIALLY EQUIVALENT 1
TRISTEL SOLUTIONS LIMITED
  GRANTED 1

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