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Comfort Rubber Gloves Industries Sdn. Bhd.

FDA 510(k) & PMA Approved Devices — 15 products

Total Devices15
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K250069 Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less ProteinLYY2025-04-29 View
510(k) K240269 Nitrile Powder Free Examination Gloves Biodegradable (Green)LZA2024-10-25 View
510(k) K241528 Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis PotentialLZA2024-08-06 View
510(k) K192954 Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and FentanylLZA2020-06-19 View
510(k) K200181 Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateLZA2020-04-15 View
510(k) K190080 Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)LZA2019-06-27 View
510(k) K180476 Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy DrugsLZC2018-05-15 View
510(k) K171541 Powder Free Nitrile Examination Gloves (Orange)LZA2017-09-20 View
510(k) K162405 Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White); Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (Blue)LZA2017-03-28 View
510(k) K110297 POWDER FREE NITRILE (BLACK) EXAMINATION GLOVESLZA2011-06-15 View
510(k) K101917 COMFORT RUBBER GLOVES IND.SDN.BHD.LYY2010-10-29 View
510(k) K002065 PATIENT LATEX POLYMER COATED POWDER-FREE GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRLYY2000-08-22 View
510(k) K001042 COMFORT LATEX POWDERED PATIENT EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATELYY2000-05-23 View
510(k) K974424 COMFORT RUBBER GLOVES INDUSTRIES SDN BHDLYY1998-04-23 View
510(k) K935256 PATIENT EXAMINATION GLOVESLYY1994-03-09 View
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