510(k) Report

Devices descending from K121947

5 later devices reach Ets Blue Powder-Free Patient Nitrile Examination Gloves through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143477Nitrile Patient Examination gloves, Powderfree, Blue colorPrimus Gloves Pvt Limited20163—
+1K123488Linshi Nitrile Disposable Exam Gloves, Powder-FreePuyang Linshi Health Co., Ltd.20130—
+2K223102Tegamen Nitrile Examination GlovesM/S Tegamen Safety Products Private Limited20230—
+2K220697Nitrile Patient Examination Gloves, Powder FreeLalan Rubbers (Pvt), Ltd.20220—
+2K163267Nitrile Examination GloveBrightway Holdings Sdn. Bhd.20170—