510(k) Report

Devices descending from K140477

1 later device reach Biogel PS Surgical Glove Series, Biogel Skinsense Surgical Glove Series through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193573Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator…Molnlycke Health Care Us, LLC20200—