510(k) Report

Devices descending from K101596

11 later devices reach Kimberly-Clark Purple Nitrile Powder-Free Exam Glove (Chemotherapy Glove) and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200633Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile…0 & M Halyard, Inc.20204—
+1K113423Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free Exam GloveKimberly-Clark Corp.20125—
+2K213929Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs…O&M Halyard, Inc.20221—
+2K220547PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free…O&M Halyard, Inc.20221—
+2K162294Brightway Brand Nitrile Examination Gloves 12”, Powder Free, [Purple] Tested for Use…Brightway Holdings Sdn. Bhd.20170—
+2K162381HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy DrugsHealthy Glove Co., Ltd.20170—
+2K160709HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam GlovesHalyard Health20162—
+3K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile…O&M Halyard, Inc.20260—
+3K243604Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested…O&M Halyard, Inc.20250—
+3K241909Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for…O&M Halyard, Inc.20240—
+3K182096Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy DrugsOwens & Minor Halyard, Inc.20180—