510(k) Report

Devices descending from K171378

3 later devices reach Non-Sterile, Single use, Powder-free examination glove tested for use with… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223903Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with…Semperit Investments Asia Pte, Ltd.20232—
+2K233990Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and…Shandong Xingyu Gloves Co., Ltd.20240—
+2K233520Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with…Anhui Powerguard Technology Co., Ltd.20240—