Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 31
- Latest Decision
- 2020-09-10
Clearances · page 17 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K202008 | Disposable Vinyl Glove | Best Care Trading Co., Ltd. | LYZ | Class I | 2020-09-10 |
| K192538 | BD Syringe NRFit Lok and BD Syringe NRFit Slip | Becton, Dickinson and Company | QEH | Class II | 2020-09-04 |
| K192111 | Biodegradable Nitrile Examination Powder Free Glove, Green | Top Glove Sdn. Bhd. | LZA | Class I | 2020-09-03 |
| K201900 | 3D GraftRasp System | Surgentec | FMF | Class II | 2020-09-03 |
| K191640 | TK Intravascular Administration Set | Anhui Tiankang Medical Technology Co., Ltd. | FPA | Class II | 2020-08-26 |
| K200373 | Deltaven Fast Flash Closed I.V. Catheter Systems | Delta Med Spa | FOZ | Class II | 2020-08-26 |
| K193338 | Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes | Shenzhen Med-Link Electronics Tech Co., Ltd. | FLL | Class II | 2020-08-25 |
| K192464 | Injection Pen Needle | Gangan Medical Technology Jiangsu Co., Ltd. | FMI | Class II | 2020-08-25 |
| K201772 | Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | Hartalega NGC Sdn. Bhd. | LZA | Class I | 2020-08-25 |
| K192291 | TidalPort-AP Implantable Apheresis Vascular Access Port | Norfolk Medical Products, Inc. | PTD | Class II | 2020-08-20 |
| K200093 | Synthetic Nitrile Patient Exam Gloves, Powder Free, Blue, Tested for Use w/Chemotherapy Drug | Anhui Lntco Medical Products Co., Ltd. | LZA | Class I | 2020-08-20 |
| K201099 | BD PhaSeal Optima Closed System Drug Transfer Device | Becton, Dickinson and Company | ONB | Class II | 2020-08-12 |
| K201953 | OMNI PLUS Surgical System | Sight Sciences, Inc. | MRH | Class II | 2020-08-11 |
| K201286 | 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch | Nurse Assist, LLC | NGT | Class II | 2020-08-11 |
| K192075 | ProSeal Closed System drug Transfer Device (CSTD) | Epic Medical Pte. , Ltd. | ONB | Class II | 2020-08-07 |
| K193278 | MedSource CathMED IV Catheter | Medsource Labs | FOZ | Class II | 2020-08-07 |
| K193066 | Steripack cases and Tray Systems | Avalign Technologies, Inc. | KCT | Class II | 2020-08-06 |
| K191644 | TK Safety Needle | Anhui Tiankang Medical Technology Co., Ltd. | FMI | Class II | 2020-08-06 |
| K200858 | Mini Sterilizable Tray | Implant Direct Sybron Manufacturing, LLC | KCT | Class II | 2020-08-06 |
| K201530 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey) | Hartalega NGC Sdn. Bhd. | LZA | Class I | 2020-08-05 |
| K201531 | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | Hartalega Sdn Bhd | LZA | Class I | 2020-08-05 |
| 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 Cuff | Medline Industries, Inc. | LZA | Class I | 2020-08-04 |
| K200280 | MEDRAD Imaging Bulk Package Transfer Spike | Bayer Medical Care, Inc. | PQH | Class II | 2020-07-30 |
| K192681 | Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type) | Jiangsu Kangbao Medical Equipment Co., Ltd. | FPA | Class II | 2020-07-28 |
| K200242 | StaClear Syringe | Tribofilm Research, Inc. | QLY | Class II | 2020-07-27 |
| K193625 | Disposable Temperature Probe | Shenzhen Changke Connect Electronics Co., Ltd. | FLL | Class II | 2020-07-24 |
| K193528 | Empty EVA Bag | Haemotronic S.P.A. | KPE | Class II | 2020-07-22 |
| K193603 | Benesta Medical Sterilization Tray | Caldera Medical, Inc. | KCT | Class II | 2020-07-20 |
| K192366 | Intravascular Extension Sets and Accessories | Baxter Healthcare Corporation | FPA | Class II | 2020-07-20 |
| K193022 | Retractable Safety Insulin Syringe | Jiangsu Caina Medical Co.,Ltd | MEG | Class II | 2020-07-20 |
| K193526 | Syringe with safety needle, Safety needle | Jiangsu Caina Medical Co.,Ltd | FMF | Class II | 2020-07-17 |
| K200578 | Infrared Thermometer Model Number RN-50A,RN-50B | Ningbo Ranor Medical Science & Technology Co., Ltd. | FLL | Class II | 2020-07-16 |
| K200531 | iHealth Infrared No-Touch Forehead Thermometer | Andon Health Co, Ltd. | FLL | Class II | 2020-07-15 |
| K201234 | BD SoloShot Mini Syringe/ BD Auto Disable Syringe | Becton, Dickinson and Company | FMF | Class II | 2020-07-15 |
| K200325 | Orbit Subretinal Delivery System | Orbit Biomedical | FMF | Class II | 2020-07-14 |
| K201338 | Allograft MIS Delivery System | Lifenet Health | FMF | Class II | 2020-07-13 |
| K200960 | Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs) | Medline Industires, Inc. | LZA | Class I | 2020-07-13 |
| K200599 | Digital Thermometer | Joytech Healthcare Co. , Ltd. | FLL | Class II | 2020-07-08 |
| K200766 | 3M Attest Steam Chemical Integrator Test Pack | 3M Company | FRC | Class II | 2020-07-02 |
| K192385 | ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable | Ivwatch, LLC | PMS | Class II | 2020-07-02 |
| K200272 | Terragene Chemdye | Terragene S.A. | JOJ | Class II | 2020-06-30 |
| K200471 | Infrared Thermometer Model Number RN-60A,RN-60B | Ningbo Ranor Medical Science & Technology Co., Ltd. | FLL | Class II | 2020-06-19 |
| K200671 | Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for | Ansell Healthcare Products, LLC | LZA | Class I | 2020-06-19 |
| K192954 | Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl | Comfort Rubber Gloves Industries Sdn. Bhd. | LZA | Class I | 2020-06-19 |
| K192910 | STATClave G4 Chamber Autoclave | Scican , Ltd. | FLE | Class II | 2020-06-19 |
| K201220 | Aerus Medical Guardian,model F170A | Aerus Medical, LLC | FRA | Class II | 2020-06-17 |
| K193253 | Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 | Shenzhen Changkun Technology Co., Ltd. | FLL | Class II | 2020-06-17 |
| K200967 | mCare(R) Powder Free Nitrile Orange Examination Gloves | Mercator Medical (Thailand), Ltd. | LZA | Class I | 2020-06-06 |
| K192550 | 3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H | 3M Company | FRC | Class II | 2020-06-05 |
| K193150 | Latex Examination Powder Free Glove, Aloe Vera | Top Glove Sdn. Bhd. | LZA | Class I | 2020-06-05 |
| K193555 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate | Ever Global (Vietnam) Enterprise Corp | LZC | Class I | 2020-06-04 |
| K200536 | 3MTM AttestTM Rapid 5 Steam-Plus Test Pack | 3M Complany | FRC | Class II | 2020-06-01 |
| K200629 | Aspire Mechanical Aspirator G | Control Medical Technology | FMF | Class II | 2020-05-29 |
| K190559 | SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports | AngioDynamics, Inc. | LJT | Class II | 2020-05-22 |
| K200126 | VERIFY Assert Self-Contained Biological Indicator | STERIS Corporation | FRC | Class II | 2020-05-22 |
| K200252 | Getinge Assured MI Steam Migrating Integrator | Steritec Products Mfg Co, Inc. | JOJ | Class II | 2020-05-21 |
| K191362 | LifeFlow Blood System | 410 Medical, Inc. | FPA | Class II | 2020-05-20 |
| K200431 | 3D GraftRasp System | Surgentec | FMF | Class II | 2020-05-18 |
| K192222 | EZ-Inject Single use Needle | Poonglim Pharmatech, Inc. | FMI | Class II | 2020-05-12 |
| K192866 | Chemfort CSTD | Simplivia Healthcare , Ltd. | ONB | Class II | 2020-05-07 |
| K200453 | NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-AC | Yty Industry (Manjung) Sdn Bhd | LZA | Class I | 2020-05-01 |
| K200606 | O-Genesis Graft Delivery System | Orthofix, Inc. | FMF | Class II | 2020-05-01 |
| K200240 | Turbett Instrument Pod | Turbett Surgical, Inc. | FRG | Class II | 2020-04-30 |
| K192246 | Biowy PICC Catheter S Kit | Biowy Corporation | LJS | Class II | 2020-04-30 |
| K193213 | Vicks VNT200 No Touch Forehead Thermometer | Kaz USA, Inc., A Helen of Troy Company | FLL | Class II | 2020-04-28 |
| K200581 | Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | Hartalega NGC Sdn. Bhd. | LZA | Class I | 2020-04-25 |
| K192230 | MF SAFECATH | Medifirst Co., Ltd. | FOZ | Class II | 2020-04-23 |
| K190984 | Infrared Forehead Thermometer | Xiamen Ants Bro Technology Co., Ltd. | FLL | Class II | 2020-04-22 |
| K192082 | Droplet Pen Needle 34G | Htl-Strefa S.A | FMI | Class II | 2020-04-21 |
| K192154 | Rio Vial-to-Bag Drug Reconstitution Device | Icu Medical | LHI | Class II | 2020-04-20 |
| K192382 | CapKlenZ | Star Mountain Medical, Inc. | QBP | Class II | 2020-04-20 |
| K193561 | Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch | Weihai Xingtai Packaging Products Co., Ltd. | FRG | Class II | 2020-04-15 |
| K200181 | Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Comfort Rubber Gloves Industries Sdn. Bhd. | LZA | Class I | 2020-04-15 |
| K200092 | 3MTM AttestTM Mini Auto-reader 490M | 3M | FRC | Class II | 2020-04-15 |
| K200500 | Molekule Air Pro RX | Molekule, Inc. | FRA | Class II | 2020-04-15 |
| K192781 | UroLift System Procedure Kit Sterilization Tray | Neotract, Inc. | KCT | Class II | 2020-04-14 |
| K192679 | Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use | Gemtier Medical (Shanghai), Inc. | MEG | Class II | 2020-04-10 |
| K200072 | KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid | Kimberly-Clark Corporation | LZA | Class I | 2020-04-10 |
| K200326 | Powder Free Nitrile Examination Glove (Aqua Green) | Riverstone Resources Sdn Bhd | LZA | Class I | 2020-04-09 |
| K200539 | Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl | Sri Trang Gloves (Thailand) Public Company Limited | LZA | Class I | 2020-04-09 |
| K200632 | TCAT TKA Instrument Tray Set | THINK Surgical, Inc. | KCT | Class II | 2020-04-08 |
| K200266 | BD Centro Vena Acute Central Line (7 French Dual Lumen) | Bard Access Systems, Inc. (Bard Has Joined Bd) | FOZ | Class II | 2020-04-07 |
| K193654 | BlueStar Rx | Welldoc, Inc. | MRZ | Class II | 2020-04-07 |
| K200019 | Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black) | Hartalega NGC Sdn. Bhd. | LZA | Class I | 2020-04-06 |
| K200319 | HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable | Deroyal Industries, Inc. | FMT | Class II | 2020-04-02 |
| K192445 | QwikCheck Chemical Indicators | Serim Research Corporation | JOJ | Class II | 2020-04-02 |
| K192676 | Introcan Safety 2 IV Catheter 18-24 gauge | B.Braun Medical, Inc. | FOZ | Class II | 2020-04-01 |
| K192056 | JJ Series Container System | Aesculap, Inc. | KCT | Class II | 2020-03-27 |
| K193121 | GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims | Eco Medi Glove Sdn. Bhd. | LZA | Class I | 2020-03-20 |
| K193581 | Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster | Sri Trang Gloves (Thailand) Public Company Limited | LZA | Class I | 2020-03-20 |
| K191658 | IV Sets not made with PVC | B.Braun Medical, Inc. | FPA | Class II | 2020-03-19 |
| K193582 | SterilContainer S2 System | Aesculap, Inc. | KCT | Class II | 2020-03-17 |
| K191753 | Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For Use with Chemotherapy Drugs) | Medline Industries, Inc. | LZA | Class I | 2020-03-17 |
| K193110 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | 3M Healthcare | QKM | Class II | 2020-03-13 |
| K192241 | Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | O&M Haylard, Inc. | LZA | Class I | 2020-03-13 |
| K200263 | Health Line CT Midline Catheter | Health Line International Corporation | FOZ | Class II | 2020-03-12 |
| K191910 | SpaceStation MRI | B. Braun Melsugen AG | MRZ | Class II | 2020-03-12 |
| K190918 | SwabTip Male Disinfectant Cap | Icu Medical | QBP | Class II | 2020-03-06 |
| K191566 | Avinent Surgical Tray | Avinent Implant System S.L.U. | KCT | Class II | 2020-03-06 |
| K193101 | Omnifix Low Dead Space Luer Lock Syringe | B.Braun Medical, Inc. | FMF | Class II | 2020-03-05 |
15,723 clearances in the General Hospital panel. Data: openFDA.