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The gown is intended to protect the wearer from blood and other body fluids encountered during surgery

This surgical gown is similar in design and composition to the Kimberly Clark gown identified in a pre-market notification #K781682. The Kappler Med-Guard surgical gown is constructed from a tri-layer composite material which is a 100% polypropylene. The specific arrangement is spunbonded polypropylene/meltblown polypropylene film/spunbonded polypropylene. The fabric is treated with an anti-static agent.

The TE Gown is intended to provide the wearer an increased level of blood and other body fluid protection during certain surgical procedures that result in excessive blood exposures by providing total encapsulation.

The COOL-ZONE System is either a gown or hood that are similar to the Kappler Pro/Vent Surgical Gown which was the subject of Premarket Notification #K932694. The fabric in the COOL-20NE gown and hood is identical to the fabric in the Pro/Vent Surgical Gown. The Pro/Vent TE Gown and Hood are constructed from the same fabric as the predicate device. The design of the gown differs in that the gament provides totally encapsulated protection to the wearer. Total encapsulation means total coverage of the entire upper body, thus providing greater protection than conventional surgical apparel.. The TE Gown utilizes a mylar face shield for visibility. A zipper is located in the back of the garment. The TE Hood provides the same level of face and head protection, but does not extend down as far on the body. It will typically be worn with another surgical gown.