510(k) Report

Devices descending from K083755

16 later devices reach Non-Sterile, Powder Free Nitrile Examination Glove, Lavender Blue Color… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182241Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with…Sri Trang Gloves (Thailand) Co., Ltd.20198—
+1K171378Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy…Semperit Investments Asia Pte, Ltd.20173—
+1K121549Non-Sterile, Powder-Free Nitrile Examination Glove, BlueSiam Sempermed Corp., Ltd.20121—
+1K122363Non-Sterile, Powder Free Nitrile Examination Gloves, BlueSiam Sempermed Corp., Ltd.20120—
+2K223903Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with…Semperit Investments Asia Pte, Ltd.20232—
+2K200072KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy…Kimberly-Clark Corporation20203—
+2K193581Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs -…Sri Trang Gloves (Thailand) Public Company Limited20203—
+2K142685Nitrile Examination Gloves with Aloe & Vitamin E, Powder- FreeSiam Sempermed Corp., Ltd.20150—
+3K233990Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and…Shandong Xingyu Gloves Co., Ltd.20240—
+3K233520Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with…Anhui Powerguard Technology Co., Ltd.20240—
+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—
+3K203236Rhino Health Non-Sterile, Powder-free Nitrile Exam GloveRhino Health, Inc.20212—
+3K202416Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the…Kimberly Clark Corporation20200—
+4K221082Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use…Rhino Health, Inc.20221—
+5K223859Rhino Non-sterile Powder-Free Nitrile Exam Glove – Periwinkle Color Tested for Use with…Rhino Health, Inc.20230—