510(k) Report

Devices descending from K191230

3 later devices reach Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG*… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231938Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for…O&M Halyard, Inc.20241—
+1K220541PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free…O&M Halyard, Inc.20220—
+2K243133Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use…Kl-Kepong Rubber Products Sdn. Bhd.20250—