510(k) Report

Devices descending from K980942

4 later devices reach Regent Biogel Indicator Inner Surgical Glove through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101163Biogel Orthopro Indicator UndergloveMolnlycke Health Care USA20100—
+1K071565Biogel Indicator Underglove with Non-Pyrogenic StatementMolnlycke Health Care Us, LLC20071—
+1K062847Biogel Eclipse Indicator UndergloveMolnlycke Health Care Us, LLC20061—
+2K071414Biogel Eclipse, Latex, Powder Free, Indicator Underglove with Protein Content Labeling…Molnlycke Health Care Us, LLC20070—