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Biocompatibility Information for Gowns

Updated: May 6, 2020

Surgical gowns are devices that are considered a surface-contacting device with intact skin with a contact duration of ≤ 24 hours. The FDA recommends that cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), and irritation or intracutaneous reactivity (ISO 10993-10) is evaluated for a device. For more information about biocompatibility end point assessment, please refer to the final guidance document entitled, “Use of International Standard ISO 10993-1, “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".


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