510(k) Report

Devices descending from K021065

1 later device reach Pre-Powdered Sterile Surgeon's Gloves (with a 50 Microgram/GM Protein Claim through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023139Romed Latex Surgical Gloves, Powdered, SterileVan Oostveen Medical B.V.20030—