510(k) Report

Devices descending from K160781

1 later device reach Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With…Harps Europe Manufacturing GmbH20250—