510(k) Report

Devices descending from K980516

3 later devices reach Regent Biogel Orthopedic Surgical Glove through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071465Biogel Orthopaedic Surgical Glove with Non-Pryogenic StatementMolnlycke Health Care Us, LLC20072—
+2K112089Biogel Orthopor Brown Surgical GloveMolnlycke Health Care Us, LLC20110—
+2K101163Biogel Orthopro Indicator UndergloveMolnlycke Health Care USA20100—