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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device medical gowns with chemotherapy labeling claims - tested for use with chemotherapy drugs
Regulation Description Surgical apparel.
Definition Medical gowns that are worn by healthcare personnel to protect both the patient and the wearer from transfer of microorganisms, body fluids, and particulate material. In addition, these gowns have been tested for permeation and breakthrough resistance against various concentrations and types of chemotherapy drugs.
Product CodeQSO
Regulation Number 878.4040
Device Class 2

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