510(k) Report

Devices descending from K053443

4 later devices reach Biogel Eclipse Non-Pyrogenic Latex Powder-Free Sterile Surgeon's Glove through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071700Biogel Sensor Surgeon's Glove with Non-Pyrogenic StatementMolnlycke Health Care Us, LLC20071—
+1K062847Biogel Eclipse Indicator UndergloveMolnlycke Health Care Us, LLC20061—
+2K112089Biogel Orthopor Brown Surgical GloveMolnlycke Health Care Us, LLC20110—
+2K071414Biogel Eclipse, Latex, Powder Free, Indicator Underglove with Protein Content Labeling…Molnlycke Health Care Us, LLC20070—