510(k) Report

Devices descending from K081027

9 later devices reach Kimberly-Clark Sterling Nitrile Powder-Free Exam Glove (Sterile) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102032Kimberly-Clark Purple Nitrile Xtra* Sterile Powder-Free Exam Glove (Chemotherapy Glove)…Kimberly-Clark Corp.20108—
+2K243172Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile*…O&M Halyard, Inc.20250—
+2K192241Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam…O&M Haylard, Inc.20200—
+2K113423Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free Exam GloveKimberly-Clark Corp.20125—
+3K162294Brightway Brand Nitrile Examination Gloves 12”, Powder Free, [Purple] Tested for Use…Brightway Holdings Sdn. Bhd.20170—
+3K162381HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy DrugsHealthy Glove Co., Ltd.20170—
+3K160709HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam GlovesHalyard Health20162—
+4K243604Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested…O&M Halyard, Inc.20250—
+4K182096Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy DrugsOwens & Minor Halyard, Inc.20180—