510(k) Report

Devices descending from K071465

2 later devices reach Biogel Orthopaedic Surgical Glove with Non-Pryogenic Statement through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112089Biogel Orthopor Brown Surgical GloveMolnlycke Health Care Us, LLC20110—
+1K101163Biogel Orthopro Indicator UndergloveMolnlycke Health Care USA20100—