510(k) Report

Devices descending from K992162

20 later devices reach Safeskin Purple Powder-Free Nitrile Examination Gloves for Use with… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170686Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy DrugsBrightway Holdings Sdn. Bhd.20174—
+1K102032Kimberly-Clark Purple Nitrile Xtra* Sterile Powder-Free Exam Glove (Chemotherapy Glove)…Kimberly-Clark Corp.20108—
+1K101596Kimberly-Clark Purple Nitrile Powder-Free Exam Glove (Chemotherapy Glove) and…Kimberly-Clark201011—
+2K243172Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile*…O&M Halyard, Inc.20250—
+2K200633Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile…0 & M Halyard, Inc.20204—
+2K200072KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy…Kimberly-Clark Corporation20203—
+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—
+3K231435KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy…Kimberly-Clark Corporation20230—
+3K231021KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy…Kimberly-Clark Corporation20230—
+3K213929Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs…O&M Halyard, Inc.20221—
+3K220547PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free…O&M Halyard, Inc.20221—
+3K202416Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the…Kimberly Clark Corporation20200—
+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—
+4K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile…O&M Halyard, Inc.20260—
+4K243604Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested…O&M Halyard, Inc.20250—
+4K241909Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for…O&M Halyard, Inc.20240—
+4K182096Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy DrugsOwens & Minor Halyard, Inc.20180—