510(k) Report

Devices descending from K032942

4 later devices reach Profeel Powder Free, Ploymer Coated Polyisoprene Surgical Gloves, Sterile through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222058Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy…Wrp Asia Pacific Sdn. Bhd.20221—
+1K040503Aloetouch Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with…Wrp Asia Pacific Sdn. Bhd.200411
+2K230578Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with…Wrp Asia Pacific Sdn. Bhd.20230—
+2K051562Nuzone Syngard Powder Free Polymer Coated Polyisoprene Sterile Surgical Glove - Aloe…Terang Nusa Sdn Bhd20050—