510(k) Report

Devices descending from K013560

2 later devices reach Sempermed Supreme, Sizes 5.5, 6, 6.5, 7, 7.5, 8, 8.5, and 9 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160781Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons GlovesSemperit Investments Asia Pte, Ltd.20171—
+2K250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With…Harps Europe Manufacturing GmbH20250—