510(k) Report

Devices descending from K062764

18 later devices reach Powder-Free Nitrile Patient Examination Glove, White (Non-Colored) and Blue… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121947Ets Blue Powder-Free Patient Nitrile Examination GlovesNorthstar Healthcare Holdings20125—
+1K111772Powder Free Nitrile Patient Examination Glove, Blue Colored and White (Non-Colored).…Kossan Latex Industries (M)Sdn Bhd201111—
+2K143477Nitrile Patient Examination gloves, Powderfree, Blue colorPrimus Gloves Pvt Limited20163—
+2K123469Powder Free Nitrile Patient Examination Glove, Blue and White Colored, Non-SterileWear Safe (Malaysia) Sdn Bhd - Facility II201310—
+2K123488Linshi Nitrile Disposable Exam Gloves, Powder-FreePuyang Linshi Health Co., Ltd.20130—
+3K223102Tegamen Nitrile Examination GlovesM/S Tegamen Safety Products Private Limited20230—
+3K220697Nitrile Patient Examination Gloves, Powder FreeLalan Rubbers (Pvt), Ltd.20220—
+3K171737Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination GlovesAnsell Healthcare Products, LLC20170—
+3K163267Nitrile Examination GloveBrightway Holdings Sdn. Bhd.20170—
+3K142862POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).Careplus (M) Sdn Bhd20158—
+4K201857Powder Free Nitrile Examination Glove Black and Dual Color White-BlueCareplus (M) Sdn Bhd20211—
+4K172015Powder Free Nitrile Examination Gloves, Blue (Colored)Careglove Global Sdn. Bhd.20175—
+5K232550Nitrile Examination Gloves, Dual Color Black-BlueShanxi Hongjin Plastic Technology Co., Ltd.20230—
+5K220442Synguard Nitrile Exam GloveTianjin Aoshang Outdoor Equipment Co., Ltd.20222—
+5K212014Medical Nitrile Examination GlovesJiangxi Ronglai Medical Technology Co., Ltd.20210—
+5K211540Edma Synthetic Nitrile Examination GlovesEdma Group, LLC20210—
+6K253160Syntex Exam GlovesBasic Medical Technology, Inc.20260—
+6K232576Medical Nitrile Examination GlovesJiangsu Complete Sincerity Medical New Materials Co., Ltd.20230—