510(k) Report

Devices descending from K113423

5 later devices reach Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free Exam Glove through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162294Brightway Brand Nitrile Examination Gloves 12”, Powder Free, [Purple] Tested for Use…Brightway Holdings Sdn. Bhd.20170—
+1K162381HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy DrugsHealthy Glove Co., Ltd.20170—
+1K160709HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam GlovesHalyard Health20162—
+2K243604Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested…O&M Halyard, Inc.20250—
+2K182096Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy DrugsOwens & Minor Halyard, Inc.20180—