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FDA 510(k) Applications Submitted by Comfort Rubber Gloves Industries Sdn. Bhd.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K190080
01/16/2019
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)
Comfort Rubber Gloves Industries Sdn. Bhd.
K180476
02/22/2018
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
Comfort Rubber Gloves Industries Sdn. Bhd.
K171541
05/26/2017
Powder Free Nitrile Examination Gloves (Orange)
Comfort Rubber Gloves Industries Sdn. Bhd.
K192954
10/21/2019
Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl
Comfort Rubber Gloves Industries Sdn. Bhd.
K200181
01/24/2020
Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Comfort Rubber Gloves Industries Sdn. Bhd.
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