510(k) Report

Devices descending from K200633

4 later devices reach Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213929Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs…O&M Halyard, Inc.20221—
+1K220547PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free…O&M Halyard, Inc.20221—
+2K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile…O&M Halyard, Inc.20260—
+2K241909Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for…O&M Halyard, Inc.20240—