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Administration (FDA). In December 2015, the FDA issued new, more stringent guidance3 for pre-market verification of surgical gowns. Before performance claims are made on labeling and published materials, surgical gowns are thoroughly reviewed by the FDA to ensure that: The gown complies with the claimed liquid barrier Sterile Surgical Gowns Disposable Medical Gowns Our factory is a professional sterile surgical gowns suppliers, we supply you various disposable medical gowns and disposable operation gowns with CE and ISO Certification Surgical Gowns - Cardinal HealthWe inform and craft the right surgical gown for the right procedure so that your choice in barrier protection becomes as intuitive as the care you dedicate to patients. AAMI Level 3 surgical gowns are intended to be used in procedures with a moderate risk of exposure.
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