Device typeSurgical/examination garment kit: A collection of apparel items intended to be worn by healthcare staff during a patient examination or surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. It consists of one or more of the following types of items (which may be worn over a scrub suit): gowns, aprons, shoe covers, sleeve covers, caps, drapes, gloves and surgical face masks. It may in addition include items intended to be worn by the patient to prevent cross-contamination, and hand sanitizing products (e.g., alcohol gel). This is a single-use device.
FDA categoryBlood borne pathogen response kit
Device ID00810010894946
Catalog numberAMM21275
AvailabilityOver the counter
Single useYes
LatexNot made with natural rubber latex
MRI safetyLabeling does not contain MRI Safety Information