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.
K240269 01/31/2024 Nitrile Powder Free Examination Gloves Biodegradable (Green) Comfort Rubber Gloves Industries Sdn. Bhd.
K250069 01/10/2025 Powder Free Natural Rubber Latex Examination Gloves û Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein Comfort Rubber Gloves Industries Sdn. Bhd.
K241528 05/30/2024 Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential Comfort Rubber Gloves Industries Sdn. Bhd.


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