Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 32
- Latest Decision
- 2022-11-23
Clearances · page 9 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K222534 | Nitrile Patient Examination Glove | Jiangxi Jiangxi Zhonghong Pulin Medical Products Co., Ltd. | LZA | Class I | 2022-11-23 |
| K211507 | Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) | Beiang Air Tech , Ltd. | FRF | Class II | 2022-11-22 |
| K221069 | Infusion Sets for Single Use with Needles | Sichuan Prius Biotechnology Co., Ltd. | FPA | Class II | 2022-11-21 |
| K221075 | Infusion Sets for Single Use | Sichuan Prius Biotechnology Co., Ltd. | FPA | Class II | 2022-11-21 |
| K221078 | Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use | Sichuan Prius Biotechnology Co., Ltd. | FPA | Class II | 2022-11-21 |
| K221165 | Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl and Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl | Sri Trang Gloves (Thailand) Public Company Limited | LZA | Class I | 2022-11-20 |
| K220558 | Blood Administration Sets | Baxter Healthcare Corporation | BRZ | Class II | 2022-11-17 |
| K221178 | Disposable Insulin Pen Needle | Ningbo Medsun Medical Co., Ltd. | FMI | Class II | 2022-11-17 |
| K213981 | Nitrile Examination Gloves | Emerald Glove Manufacturing Sdn Bhd | LZA | Class I | 2022-11-12 |
| K222225 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) | Hartalega NGC Sdn. Bhd. | LZA | Class I | 2022-11-11 |
| K220230 | AMSure Enteral Feeding Pump | Amsino International, Inc. | LZH | Class II | 2022-11-10 |
| K223198 | BD Intraosseous Vascular Access System EMS Powered Driver (D001003) | Bard Access Systems | MHC | Class II | 2022-11-10 |
| K222898 | SafeSource Direct Blue Powder-Free Nitrile Exam Gloves | Safesource Direct, LLC | LZA | Class I | 2022-11-07 |
| K212764 | Medwell Technology Ltd Syringes, various sizes | Medwell Technology, Ltd. | FMF | Class II | 2022-11-04 |
| K222124 | Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | FMI | Class II | 2022-11-04 |
| K221045 | Insulin Syringes without needle | Berpu Medical Technology Co., Ltd. | FMF | Class II | 2022-11-03 |
| K221518 | NP Medical nCompass Extension Set with Stabilizing Base | Np Medical | FPA | Class II | 2022-11-03 |
| K220371 | Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with the Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit) | Summit Glove, Inc. | LZA | Class I | 2022-11-02 |
| K211816 | Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Brightway Holdings Sdn. Bhd. | LZA | Class I | 2022-11-02 |
| K223320 | Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Lingshi Hongruida Health Protection Technology Co., Ltd. | LZA | Class I | 2022-11-02 |
| K222508 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248 | 3M Company | JOJ | Class II | 2022-11-01 |
| K221247 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle | Jiangsu Kangbao Medical Equipment Co., Ltd. | MEG | Class II | 2022-11-01 |
| K220890 | IO Needle Safety Sheath | Actuated Medical, Inc. | FMI | Class II | 2022-10-31 |
| K221667 | Non Sterile Powder Free Latex Examination Glove | New Era Medicare Sdn. Bhd. | LYY | Class I | 2022-10-28 |
| K222514 | S.I.N. Instrument Kits | S.I.N. Sistema DE Implante Nacional S.A. | KCT | Class II | 2022-10-27 |
| K222348 | JR MEDIC | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | LYY | Class I | 2022-10-27 |
| K221374 | Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) | Hebei Titans Hongsen Medical Technology Co., Ltd. | LYY | Class I | 2022-10-26 |
| K223235 | Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) | Pt. Sintong Unigolden Glove | LZA | Class I | 2022-10-26 |
| K222498 | Medical Examination Gloves (Nitrile) (XS, S, M, L, XL) | Humanwell Healthcare Group Medical Supplies Co., Ltd. | LZA | Class I | 2022-10-26 |
| K221169 | JR MEDIC Nitrile Examination Gloves Powder Free- Black | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | LZA | Class I | 2022-10-25 |
| K222349 | JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | LZA | Class I | 2022-10-21 |
| K213429 | AccuSert Needle Inserter | Emed Technologies Corporation | KZH | Class II | 2022-10-20 |
| K220992 | Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple | Ever Global (Vietnam) Enterprise Corporation | LYZ | Class I | 2022-10-19 |
| K222298 | Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid | Onetexx Sdn Bhd | LZA | Class I | 2022-10-18 |
| K222721 | Violet Nitrile Powder Free Patient Examination Glove, Non Sterile | Safeskin Retailing (Hk) Limited | LZA | Class I | 2022-10-18 |
| K221308 | Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle | Jiangxi Maidikang Medical Devices Co., Ltd. | FMF | Class II | 2022-10-17 |
| K222074 | Powder Free Nitrile Examination Gloves (Blue, Black, White and/or Violet Blue), Powder Free Latex Examination Gloves | Zibo Langu New Material Technology Co., Ltd. | LZA | Class I | 2022-10-17 |
| K222791 | SafeBreak Vascular | Lineus Medical, LLC | QOI | Class II | 2022-10-16 |
| K221504 | BD Surgiphor Antimicrobial Irrigation System | Bd | FQH | Class II | 2022-10-14 |
| K213183 | Safety Insulin Pen Needles | Zhejiang Kindly Medical Devices Co., Ltd. | FMI | Class II | 2022-10-14 |
| K222087 | SCIg60 Infusion System | Emed Technologies Corporation | PKP | Class II | 2022-10-13 |
| K220102 | MOST-T Autoclave | Shinva Medical Instrument Co., Ltd. | FLE | Class II | 2022-10-12 |
| K222744 | Sol-M Luer Lock Syringe | Sol-Millennium Medical, Inc. | FMF | Class II | 2022-10-11 |
| K223008 | Disposable Vinyl Examination Gloves | Jiangxi Handspro Products Solutions Co., Ltd. | LYZ | Class I | 2022-10-08 |
| K220267 | AMSafe NeuFlo Needleless Connector | Amsino International, Inc. | FPA | Class II | 2022-10-07 |
| K222714 | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs | Guangdong Kingfa Sci. & Tech.Co., Ltd. | LZA | Class I | 2022-10-07 |
| K221492 | SteriTite Container System with MediTray Parts | Case Medical, Inc. | KCT | Class II | 2022-10-07 |
| K220057 | Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization | Shinva Ande Healthcare Apparatus Co., Ltd. | MEG | Class II | 2022-10-07 |
| K221170 | Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107 | Shenzhen AOJ Medical Technology Co., Ltd. | FLL | Class II | 2022-10-07 |
| K220365 | Gemini Sterilization Wrap | Medline Industries, LP | FRG | Class II | 2022-10-06 |
| K221066 | Sterile Hypodermic Needles for Single Use | Sichuan Prius Biotechnology Co., Ltd. | FMI | Class II | 2022-10-04 |
| K221079 | Sterile Hypodermic Syringes for Single Use | Sichuan Prius Biotechnology Co., Ltd. | FMF | Class II | 2022-10-04 |
| K221073 | Sterile Hypodermic Syringes for Single Use with Safety Needles | Sichuan Prius Biotechnology Co., Ltd. | MEG | Class II | 2022-10-04 |
| K221080 | Sterile Safety Hypodermic Needles for Single Use | Sichuan Prius Biotechnology Co., Ltd. | FMI | Class II | 2022-10-04 |
| K221068 | Sterile Hypodermic Syringes for Single Use with Needles | Sichuan Prius Biotechnology Co., Ltd. | FMF | Class II | 2022-10-04 |
| K212262 | PCA Syringe Sets | Baxter Healthcare Corporation | FPA | Class II | 2022-10-03 |
| K222937 | Disposable Nitrile Examination Glove | Jiangsu Cureguard Glove Co., Ltd. | LZA | Class I | 2022-10-01 |
| K221378 | Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile | Tec Gloves Industry (M) Sdn.Bhd. | LZA | Class I | 2022-09-30 |
| K222005 | S.I.N. Instrument Kits | S.I.N. - Sistema DE Implante Nacional S.A. | KCT | Class II | 2022-09-29 |
| K222442 | DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue) | Anhui Bytech Medical Supplies Co., Ltd. | LYZ | Class I | 2022-09-28 |
| K222328 | SteriCUBE® Multiple Tray Sterilization Systems | Stericube, LLC | KCT | Class II | 2022-09-28 |
| K222615 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate | STERIS Corporation | MED | Class II | 2022-09-28 |
| K221211 | Infrared thermometer | Shenzhen Yolanda Technology Co., Ltd. | FLL | Class II | 2022-09-27 |
| K221473 | Flowart | Asset Medikal Tasarim As. | FPA | Class II | 2022-09-26 |
| K212751 | Powder Free Nitrile Examination Glove | Dainam Glove Joint Stock Company | LZA | Class I | 2022-09-24 |
| K222693 | Single-use medical latex examination gloves (LG100) | Fitone Latex Products Co., Ltd. Guangdong | LYY | Class I | 2022-09-24 |
| K222342 | Betel Gloves Nitrile Examination Glove Powder Free | Betel Care Sdn. Bhd. | LZA | Class I | 2022-09-24 |
| K221887 | Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile Examination Glove, White Color | Guangdong Kingfa Sci. & Tech.Co., Ltd. | LZA | Class I | 2022-09-24 |
| K222294 | Black Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid | Onetexx Sdn Bhd | LZA | Class I | 2022-09-24 |
| K222152 | 3M Attest Hydrogen Peroxide Indicator Tape 1228 | 3M Company | JOJ | Class II | 2022-09-23 |
| K221481 | NeutrArt | Asset Medikal Tasarim As. | FPA | Class II | 2022-09-23 |
| K222804 | Irrisept Antimicrobial Wound Lavage | Irrimax Corporation | FQH | Class II | 2022-09-22 |
| K222642 | Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug) | Inner Mongolia Cureguard Medical Technology Co., Ltd. | LZA | Class I | 2022-09-20 |
| K214056 | Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs) | Mezorrison Medical Technology (Dongying) Co., Ltd. | LZA | Class I | 2022-09-20 |
| K221227 | Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120 | Tuttnauer , Ltd. | FLE | Class II | 2022-09-20 |
| K213013 | Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe | Jeil Tech Co., Ltd. | QNQ | Class II | 2022-09-19 |
| K220129 | Promisemed X-Safety Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | FMI | Class II | 2022-09-19 |
| K212217 | Tempo Smart Button | Eli Lilly and Company | QOG | Class II | 2022-09-16 |
| K211204 | SafePort(TM) Manifold (or Stopcock) | Elcam Medical Acal | FMG | Class II | 2022-09-15 |
| K220697 | Nitrile Patient Examination Gloves, Powder Free | Lalan Rubbers (Pvt), Ltd. | LZA | Class I | 2022-09-15 |
| K220990 | Qorda QD1 | Winix, Inc. | FRF | Class II | 2022-09-14 |
| K210929 | MagiCath II | Woo Young Medical Co., Ltd. | FOZ | Class II | 2022-09-13 |
| K220084 | Infrared Forehead Thermometer | Qingdao Yasee Medical Device Co., Ltd. | FLL | Class II | 2022-09-12 |
| K222093 | V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System | Steris | MLR | Class II | 2022-09-09 |
| K220859 | Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black) | Careglove Global Sdn. Bhd. | LZA | Class I | 2022-09-09 |
| K222440 | Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays | Steris | FRG | Class II | 2022-09-09 |
| K222048 | Spectrum IQ Infusion System with Dose IQ Safety Software | Baxter Healthcare Corporation | FRN | Class II | 2022-09-06 |
| K213855 | Arrow Pressure Injectable Midline Catheter | Arrow International, LLC Subsidiary of Teleflex Incorporated | PND | Class II | 2022-09-02 |
| K201876 | Soteria Bed Barrier | Trinity Guardion | QTV | Class I | 2022-09-01 |
| K213513 | Vented Vial Adapter 20mm | West Pharma. Services IL, Ltd. | LHI | Class II | 2022-08-31 |
| K212846 | Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use | Jiangsu Jichun Medical Devices Co., Ltd. | FMF | Class II | 2022-08-30 |
| K221164 | Powder Free Nitrile Examination Glove - Blue, Non-Sterile, Tested for use with Chemotherapy Drugs and Fentanyl | Hong Seng Gloves Sdn Bhd | LZA | Class I | 2022-08-30 |
| K211124 | Dose IQ Safety Software | Baxter Healthcare Corporation | PHC | Class II | 2022-08-30 |
| K221157 | JR Medic | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | LZC | Class I | 2022-08-30 |
| K211125 | Novum IQ Syringe Pump | Baxter Healthcare Corporation | FRN | Class II | 2022-08-30 |
| K212370 | Leaderflex Mini and Leaderflex Nano | Vygon USA | FOZ | Class II | 2022-08-29 |
| K222449 | Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) | Better Care Plastic Technology Co., Ltd. | LZC | Class I | 2022-08-27 |
| K221143 | Nitrile Exam Gloves (Blue, Black) | Hebei Astro Medical Supply Co., Ltd. | LZA | Class I | 2022-08-25 |
| K220055 | Disposable, vinyl examination gloves, Yellow | Dezhou Hengchang Medical Technology Co., Ltd. | LYZ | Class I | 2022-08-25 |
| K221648 | Iconic Latex Glove | Iconic Medicare Sdn Bhd | LYY | Class I | 2022-08-25 |
15,723 clearances in the General Hospital panel. Data: openFDA.