510(k) Report

Devices descending from K060030

4 later devices reach The Double Glove through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071465Biogel Orthopaedic Surgical Glove with Non-Pryogenic StatementMolnlycke Health Care Us, LLC20072—
+1K071565Biogel Indicator Underglove with Non-Pyrogenic StatementMolnlycke Health Care Us, LLC20071—
+2K112089Biogel Orthopor Brown Surgical GloveMolnlycke Health Care Us, LLC20110—
+2K101163Biogel Orthopro Indicator UndergloveMolnlycke Health Care USA20100—