510(k) Report

Devices descending from K082457

8 later devices reach Micro-Touch Nitratex Sterile Nitrile Powder-Free Blue Examination Gloves… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200671Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink…Ansell Healthcare Products, LLC20207—
+2K240080Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and…Syntex Healthcare Products Co., Ltd.20241—
+2K231365Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use…Anhui Intco Medical Products Co., Ltd.20241—
+2K210401Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with…Ansell Healthcare Products, LLC20212—
+3K243694Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use…Mah Sing Healthcare Sdn. Bhd.20250—
+3K250630Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with…Basic Medical Technology, Inc.20250—
+3K212148Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with…Ansell Healthcare Products, LLC20221—
+4K250342Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with…Encompass Industries Sdn. Bhd.20250—