510(k) Report

Devices descending from K171093

5 later devices reach Sterile Nitrile Patient Examination Gloves, Powderfree through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212586Amazing+Amazing Rubber Products Pvt, Ltd.20220—
+1K180452White Nitrile Examination Glove, Sterile with Chemotherapy Drugs ClaimRiverstone Resources Sdn Bhd20183—
+2K190725Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, WhiteRiverstone Resources Sdn Bhd20192—
+3K220250Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy…Grand Work Plastic Products Co., Ltd.20221—
+4K232039Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy…Grand Work Plastic Products Co., Ltd.20230—