510(k) Report

Devices descending from K201531

2 later devices reach Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251319Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and…Hartalega NGC Sdn. Bhd.20250—
+1K220249Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs…Grand Work Plastic Products Co., Ltd.20220—