510(k) Report

Devices descending from K161187

8 later devices reach EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180452White Nitrile Examination Glove, Sterile with Chemotherapy Drugs ClaimRiverstone Resources Sdn Bhd20183—
+1K171339EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy…Eco Medi Glove Sdn. Bhd.20173—
+2K233405Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test ClaimEco Medi Glove Sdn. Bhd.20230—
+2K212408Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and…Pt. Maja Agung Latexindo20221—
+2K190725Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, WhiteRiverstone Resources Sdn Bhd20192—
+3K251716Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl…Basic Medical Technology, Inc.20250—
+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—