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Medline Industries, Inc.

FDA 510(k) & PMA Approved Devices — 74 products

Total Devices74
Categories35
Latest FDA decision2023-10-26
TypeNumberDevice NameCodeDateActions
510(k) K200150 Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl)LZA2020-10-26 View
510(k) K202179 Medline Glide-On 3G Vinyl Examination Gloves (Tested for use with Chemotherapy Drugs)LYZ2020-10-26 View
510(k) K202285 Medline ENfit OTC Feeding SyringePNR2020-10-09 View
510(k) K201290 Medline DeNovo 4Pro Electrical Stimulation DeviceIPF2020-09-21 View
510(k) K201829 SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs)KGO2020-09-09 View
510(k) K193666 Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) – Regular Cuff; Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended CuffLZA2020-08-04 View
510(k) K193217 SensiCare PI and SensiCare PI Micro Surgical GlovesKGO2020-04-06 View
510(k) K192988 Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for UseKGO2020-04-01 View
510(k) K191753 Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For Use with Chemotherapy Drugs)LZA2020-03-17 View
510(k) K191915 SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe VKGO2020-03-06 View
510(k) K192820 SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs)KGO2020-02-28 View
510(k) K192641 Gemini Titan Sterilization WrapFRG2020-01-24 View
510(k) K192985 Medline Glide-On 3G Vinyl Examination GlovesLYZ2020-01-21 View
510(k) K192315 Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)LZA2020-01-10 View
510(k) K192104 Medline Sterile Power-Free Nitrile Examination Gloves - Blue (Test for Use with Chemotherapy Drugs)LZA2019-12-23 View
510(k) K191759 Medline Quick Switch Valve with ENFit ConnectorPIF2019-12-04 View
510(k) K191378 0.9% Sodium Chloride Injection, USP, Pre-filled COP SyringeNGT2019-09-15 View
510(k) K190950 Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced)FYA2019-07-04 View
510(k) K183431 Medline Digital Rectal Thermometer SheathFLL2019-06-14 View
510(k) K183335 Medline Poly-Cath Red Polymer Urethral CatheterGBM2019-06-12 View

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