510(k) Report

Devices descending from K151997

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222225Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)Hartalega NGC Sdn. Bhd.20221—
+1K162095Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy…Yty Industry (Manjung) Sdn Bhd20160—
+2K243818Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and…Hartalega NGC Sdn. Bhd.20250—