510(k) Report

Devices descending from K110921

7 later devices reach Nitrile Powder-Free Examination Gloves Tested for Use with Chemotherapy Drugs through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141623Emg Blue Nitrile Medical Examination Glove with Chemotherapy Drug Labeling ClaimEco Medi Glove Sdn. Bhd.20146—
+2K161944Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for…Shandong Baisheng Medical Products Co., Ltd.20160—
+2K161473Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr)Medline Industries, Inc.20160—
+2K152542Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and…Riverstone Resources Sdn Bhd20153—
+3K193121GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with…Eco Medi Glove Sdn. Bhd.20200—
+3K181066Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested…Eco Medi Glove Sdn. Bhd.20181—
+4K233560Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested…Eco Medi Glove Sdn. Bhd.20240—