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FDA 510(k) & PMA Approved Devices — 4 products

Total Devices4
Categories2
Latest FDA decision2023-01-27
TypeNumberDevice NameCodeDateActions
510(k) K223903 Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105)LZA2023-01-27 View
510(k) K183441 Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy DrugsLZA2019-10-04 View
510(k) K171378 Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugsLZA2017-09-14 View
510(k) K160781 Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons GlovesKGO2017-05-02 View