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The Biogel® Skinsense™ Sterile, Powder-Free, Synthetic Polyisoprene Surgical Glove is a disposable device made of synthetic material and is intended for use in hospitals and other health care facilities during invasive or non-invasive procedures for the protection of operating room personnel and patients, from microbial migration and surgical wounds from contamination.

The device in this 510(k) submission is intended for the Biogel Skinsense™ Sterile, Powder-Free, Synthetic Polyisoprene Surgical Glove (Classification number 79KGO). The Biogel Skinsense™ Sterile, Powder-Free, Synthetic Polyisoprene Surgical Glove is a disposable device made from Non-Latex synthetic rubber material, polvisoprene. Glove size is available from size 5.5 through 9.0 in a half size increment.