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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
Regulation Description Non-powdered patient examination glove.
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