510(k) Report

Devices descending from K190077

2 later devices reach Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213289Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy DrugsAnsell Healthcare Products, LLC20230—
+1K191869Biogel (R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel…Molnlycke Health Care Us, LLC20200—