510(k) Report

Devices descending from K022765

19 later devices reach Nitrile Powder-Free Examination Gloves through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102189Powder Free Nitrle Examination Gloves with Chemotherapy Labeling ClaimLatexx Manufacturing Sdn.Bhd.20120—
+1K110921Nitrile Powder-Free Examination Gloves Tested for Use with Chemotherapy DrugsCardinal Health, Inc.20117—
+1K103249Nitrile Cornflower Blue Powder-Free Examination Gloves with Tested for Use with…Cardinal Health, Inc.20102—
+1K071072Shanghai China Star Corp. Powder Free Blue Nitrile Patient Examination GloveShanghai China Star Corp20076—
+2K232764Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy…Eco Medi Glove Sdn. Bhd.20240—
+2K141623Emg Blue Nitrile Medical Examination Glove with Chemotherapy Drug Labeling ClaimEco Medi Glove Sdn. Bhd.20146—
+2K122696Powder-Free Nitrile Examination Gloves (Cool Blue)Cardinal Health, Inc.20130—
+2K090336Sunmax Enterprise Shanghai CO. Powder Free Blue Nitrile Patient Examination Glove Tested…Sunmax Enterprise Shanghai Co., Ltd.20095—
+3K161944Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for…Shandong Baisheng Medical Products Co., Ltd.20160—
+3K161473Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr)Medline Industries, Inc.20160—
+3K152542Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and…Riverstone Resources Sdn Bhd20153—
+3K102593Synthetic, Powder-Free Nitrile ExaminationZibo Yinghao Medical Products Co., Ltd.20101—
+3K101870Sunmax Vietnam CO. LTD Powder Free White Nitrile Examination GloveSunmax Vietnam Co., Ltd.20101—
+3K101943Synthetic, Powder-Free Nitrile Examination GlovesTangshan Jiteng Plastic Products Co., Ltd.20100—
+4K211667Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)Changzhou Universal Medical Equipment Co., Ltd.20210—
+4K193121GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with…Eco Medi Glove Sdn. Bhd.20200—
+4K181066Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested…Eco Medi Glove Sdn. Bhd.20181—
+4K103675Chienmax Vietnam CO. LTD Powder Free Blue Nitrile Examination GloveChienmax Vietnam Co., Ltd.20110—
+5K233560Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested…Eco Medi Glove Sdn. Bhd.20240—