510(k) Report

Devices descending from K171339

3 later devices reach EMG Blue Nitrile Examination Gloves Powder free with tested for use with… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233405Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test ClaimEco Medi Glove Sdn. Bhd.20230—
+1K212408Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and…Pt. Maja Agung Latexindo20221—
+2K251716Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl…Basic Medical Technology, Inc.20250—