510(k) Report

Devices descending from K211515

2 later devices reach Nitrile Examination Gloves through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213739Nitrile Examination GlovesHangzhou Runheng Medical Co., Ltd.20221—
+2K230633APOLLO ADVANTAGE Nitrile Examination GlovesDell Corning Corporation20230—