510(k) Report

Devices descending from K050184

8 later devices reach Biogel Skinsense Poly-Isoprene Powder-Free Non-Latex Glove through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190077Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator UndergloveMolnlycke Health Care Us, LLC20192—
+1K140477Biogel PS Surgical Glove Series, Biogel Skinsense Surgical Glove SeriesMolnlycke Health Care Us, LLC20151—
+1K141719Biogel PL Micro Surgical GloveMolnlycke Health Care Us, LLC20140—
+1K112257Biogel PI Orthopro Brown Surgical GloveMolnlycke Health Care Us, LLC20110—
+1K072169Durex Synthetic Polyisoprene Male CondomSsl Americas, Inc.200804
+2K213289Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy DrugsAnsell Healthcare Products, LLC20230—
+2K193573Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator…Molnlycke Health Care Us, LLC20200—
+2K191869Biogel (R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel…Molnlycke Health Care Us, LLC20200—