510(k) Report

Devices descending from K033564

5 later devices reach Powder Free Latex Surgeons Gloves Polymer Coated Sterile with Optional… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060030The Double GloveBiobarrier, Inc.20064—
+2K071465Biogel Orthopaedic Surgical Glove with Non-Pryogenic StatementMolnlycke Health Care Us, LLC20072—
+2K071565Biogel Indicator Underglove with Non-Pyrogenic StatementMolnlycke Health Care Us, LLC20071—
+3K112089Biogel Orthopor Brown Surgical GloveMolnlycke Health Care Us, LLC20110—
+3K101163Biogel Orthopro Indicator UndergloveMolnlycke Health Care USA20100—