510(k) Report

Devices descending from K052728

2 later devices reach Powder Free Latex Sterile Patient Examination Gloves through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171367SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX…Sanrea Healthcare Products Pvt, Ltd.20181—
+2K223298Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)Shandong Intco Medical Products Co, Ltd.20230—