Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 34
- Latest Decision
- 2022-08-24
Clearances · page 10 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K222232 | Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly | Bard Access Systems, Inc. | LJS | Class II | 2022-08-24 |
| K222212 | ivWatch Model 400 | Ivwatch, LLC | PMS | Class II | 2022-08-24 |
| K220061 | Safety Insulin Syringes | Berpu Medical Technology Co., Ltd. | MEG | Class II | 2022-08-23 |
| K220603 | Disposable Medical Safety Hypodermic Needle | Hantech Medical Device Co., Ltd. | FMI | Class II | 2022-08-23 |
| K211601 | Powder Free Latex Examination Glove, Non-Sterile | Wrp Asia Pacific Sdn. Bhd. | LYY | Class I | 2022-08-22 |
| K220363 | VPS Rhythm DLX Device with TipTracker Technology | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | LJS | Class II | 2022-08-22 |
| K212095 | SurGuard3 Safety Hypodermic Needle | Terumo Europe N.V. | FMI | Class II | 2022-08-22 |
| K213758 | Lexa PLUS RIS-311 | W&H Sterilization S.R.L. | FLE | Class II | 2022-08-19 |
| K212525 | Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices | Advcare Medical | LHI | Class II | 2022-08-19 |
| K212518 | Jeesung Safety Syringe and Single Use Needles | Jeesung Medical Co., Ltd. | MEG | Class II | 2022-08-18 |
| K212033 | Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle | Shandong Zhushi Pharmaceutical Group Co., Ltd. | FMF | Class II | 2022-08-17 |
| K213937 | Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution | O&M Halyard, Inc. | LZA | Class I | 2022-08-16 |
| K202461 | ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System | Smisson-Cartledge Biomedical, LLC | LGZ | Class II | 2022-08-12 |
| K221737 | InstaFill Graft Delivery System, SIGNIFY Bioactive | Globus Medical, Inc. | FMF | Class II | 2022-08-11 |
| K212482 | Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White | Sri Trang Gloves (Thailand) Public Company Limited | LYY | Class I | 2022-08-09 |
| K213934 | Pro Guard Nitrile Powder Free Examination Glove | Medical Glove Co., Ltd. | LZA | Class I | 2022-08-06 |
| K213993 | Powder Free Chloroprene Examination Glove Coloured (Blue, Green) | Careglove Global Sdn. Bhd. | LZA | Class I | 2022-08-05 |
| K221350 | Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) | Rubberex Alliance Products Sdn Bhd | LZA | Class I | 2022-08-05 |
| K191131 | Solidence Multipockets | Solidence Surgical Corporation | FRG | Class II | 2022-08-03 |
| K220237 | Disposable Medical Nitrile Examination Gloves | Fujian Jixiang Medical Technology Co.,Ltd | LZA | Class I | 2022-08-01 |
| K213929 | Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | O&M Halyard, Inc. | LZA | Class I | 2022-08-01 |
| K220736 | Consolidated HC Steam Sterilizer | Consolidated Machine Corp. | FLE | Class II | 2022-08-01 |
| K221773 | Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simulated Gastric Acid, and Fentanyl In Gastric Acid | Onetexx Sdn Bhd | LZA | Class I | 2022-07-30 |
| K221901 | EleGARD | Advancedcpr Solutions, LLC | FOA | Class I | 2022-07-29 |
| K214007 | HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap | Owens & Minor (O&M) Halyard, Inc. | FRG | Class II | 2022-07-27 |
| K221271 | Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) | Shandong Maida Medical Technology Co., Ltd. | LZA | Class I | 2022-07-27 |
| K221269 | Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Better Care Plastic Technology Co., Ltd. | LZA | Class I | 2022-07-27 |
| K221877 | Powder-Free Nitrile Examination Glove, Non-Sterile | Goodgloves Industries Sdn Bhd | LZA | Class I | 2022-07-23 |
| K213881 | Celerity Incubator | STERIS Corporation | FRC | Class II | 2022-07-21 |
| K213158 | Syringe with permanently attached needle | Berpu Medical Technology Co., Ltd. | FMF | Class II | 2022-07-21 |
| K220184 | Pump Alignment Syringe | Jiangsu Caina Medical Co.,Ltd | FMF | Class II | 2022-07-21 |
| K214080 | Pentaflush | Pentaferte Italia S.R.L. | NGT | Class II | 2022-07-20 |
| K220943 | Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim | Eco Medi Glove Sdn. Bhd. | LZA | Class I | 2022-07-19 |
| K213955 | 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub | Becton, Dickinson and Company | QTI | Class II | 2022-07-16 |
| K221229 | Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves | Zibo Blue Sail Health Technology Co., Ltd. | LZA | Class I | 2022-07-16 |
| K220742 | NxtGen Infant Transport Incubator | International Biomedical | FPL | Class II | 2022-07-15 |
| K220204 | Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle | Anhui Tiankang Medical Technology Co., Ltd. | FMF | Class II | 2022-07-14 |
| K214017 | Examination gloves-Type A(Latex gloves) | Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. | LYY | Class I | 2022-07-14 |
| K213574 | Nitrile Vinyl Blend Powder Free Examination Gloves (Black) | Grand Work Plastic Products Co., Ltd. | LZA | Class I | 2022-07-12 |
| K221108 | Nitrile Medical Examination Gloves | Anhui Fulewei Electronic Technology Co.,Ltd | LZA | Class I | 2022-07-12 |
| K221454 | Disposable Medical Nitrile Examination Gloves - Non Sterile | Guangzhou Kangling Biotechnology Co., Ltd. | LZA | Class I | 2022-07-12 |
| K220825 | Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves | American Nitrile Operations, LLC | LZA | Class I | 2022-07-08 |
| K220284 | Powder Free Nitrile Examination Gloves (Blue) | Kgm Gloves Sdn. Bhd. | LZA | Class I | 2022-07-08 |
| K221176 | Insulin Pen Needle | Tianjin Huahong Technology Co., Ltd. | FMI | Class II | 2022-07-01 |
| K220298 | CerroZone Mobile | Cerrozone | FRF | Class II | 2022-07-01 |
| K220834 | Powder Free Nitrile Examination Glove | Daxwell, LLC | LZA | Class I | 2022-06-29 |
| K213478 | BD Pen Needle | Becton, Dickinson and Company | FMI | Class II | 2022-06-28 |
| K211705 | 3M Attest Rapid Readout Biological Indicator, 1295 | 3M Company | FRC | Class II | 2022-06-28 |
| K220942 | 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES) | 3M Company | JOJ | Class II | 2022-06-24 |
| K213114 | BentrioTM Allergy Blocker | Altamira Therapeutics, Inc. | NUP | Class II | 2022-06-24 |
| K220756 | Introcan Safety 2 IV Catheter | B.Braun Medical, Inc. | FOZ | Class II | 2022-06-23 |
| K213739 | Nitrile Examination Gloves | Hangzhou Runheng Medical Co., Ltd. | LZA | Class I | 2022-06-22 |
| K221192 | Disposable Nitrile Powder-Free Examination Gloves | Shandong Maida Medical Technology Co., Ltd. | LZA | Class I | 2022-06-22 |
| K213274 | Qlicksmart BladeFlask UNIVERSAL | Qlicksmart Pty , Ltd. | MMK | Class II | 2022-06-22 |
| K221185 | TC Gloves | Thanh Cong Pharmaceutical and Trading Company Limited | LYY | Class I | 2022-06-22 |
| K220856 | Vial Adapter Ø13mm | Avenir Performance Européenne Medical (Apem) | LHI | Class II | 2022-06-21 |
| K220431 | Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile | One Glove Industrial Sdn Bhd | LZA | Class I | 2022-06-17 |
| DEN210004 | Zuno Smart Sterilization Container | Zuno Medical, Inc. | QJT | Class II | 2022-06-17 |
| K221226 | 1st Glove Blue Nitrile Examination Gloves Powder Free | Koove Iot Pvt. , Ltd. | LZA | Class I | 2022-06-16 |
| K220469 | Disposable Vinyl Examination Glove | Chifeng Huawei Medical Science&Technology Co., Ltd. | LYZ | Class I | 2022-06-16 |
| K221186 | TC Gloves | Thanh Cong Pharmaceutical and Trading Company Limited | LZA | Class I | 2022-06-16 |
| K220614 | MEDOJECT fine Pen Needles | Chirana T. Injecta | FMI | Class II | 2022-06-15 |
| K213173 | TrabEx Pro | Microsurgical Technologies, Inc. | MRH | Class II | 2022-06-08 |
| K220693 | Zoupure Nitrile Powder Free Examination glove | Thai Rayong Product Glove Zoupure Co., Ltd. | LZA | Class I | 2022-06-07 |
| K213448 | Powder Free Nitrile Gloves | St Future International Limited | LZA | Class I | 2022-06-06 |
| K213846 | Q2 Blood Administration Sets | Quest Medical, Inc. | FPA | Class II | 2022-06-05 |
| K220672 | Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim | Riverstone Resources Sdn Bhd | LZA | Class I | 2022-06-03 |
| K220541 | PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves | O&M Halyard, Inc. | LZA | Class I | 2022-06-02 |
| K220547 | PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves | O&M Halyard, Inc. | LZA | Class I | 2022-06-02 |
| K213588 | Q2 IV Administration Sets | Quest Medical, Inc. | FPA | Class II | 2022-06-02 |
| K212445 | freeflex+ Transfer Adapter | Fresenius Kabi AG | LHI | Class II | 2022-06-01 |
| K213753 | Purgo | Aeroclean Technologies, LLC | FRA | Class II | 2022-06-01 |
| K220488 | Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) | Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd. | LZA | Class I | 2022-06-01 |
| K212699 | Disposable Powder Free Polyethylene Examination Gloves | Mastermax Plastic (Huizhou), Ltd. | LZA | Class I | 2022-05-31 |
| K210987 | IRRIGO Wound Wash Jet System | Inopro, Inc. | FQH | Class II | 2022-05-31 |
| K212597 | Amazing+ Latex Examination Powder Free Gloves | Amazing Rubber Products Pvt, Ltd. | LYY | Class I | 2022-05-28 |
| K213141 | Biodegradable Powder Free Nitrile Examination Glove, Blue and Green colors, Low Dermatitis Potential, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution | Shen Wei USA, Inc. | LZA | Class I | 2022-05-28 |
| K212584 | Blue Nitrile Examination Gloves Powder Free | Amazing Rubber Products Pvt, Ltd. | LZA | Class I | 2022-05-28 |
| K220609 | Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color) | Encompass Industries Sdn. Bhd. | LZA | Class I | 2022-05-27 |
| K212629 | PP Care Nitrile Examination Gloves | Eg Group Product and Services Co., Ltd. | LZA | Class I | 2022-05-26 |
| K220545 | Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs | Hl Rubber Industries Sdn Bhd | LZC | Class I | 2022-05-26 |
| K212644 | Aura Storm | Invictus Lighting | FRA | Class II | 2022-05-26 |
| K220249 | Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue) | Grand Work Plastic Products Co., Ltd. | LZA | Class I | 2022-05-26 |
| K220083 | LDV((Low Dead Volume )Syringe | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | QNQ | Class II | 2022-05-25 |
| K213485 | Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E | Shenzhen AOJ Medical Technology Co., Ltd. | FLL | Class II | 2022-05-25 |
| K210748 | Well-life TM Pen Needles, Well-life TM Safety Pen Needles | W. L. Med Co., Ltd. | FMI | Class II | 2022-05-25 |
| K213191 | S-Line | Barkey GmbH & Co. KG | LGZ | Class II | 2022-05-24 |
| K211810 | Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) | Pt. Shamrock Manufacturing Corpora | LZA | Class I | 2022-05-23 |
| K220564 | 3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 1355 | 3M Company | JOJ | Class II | 2022-05-23 |
| K220155 | Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs | Motex Healthcare (Anhui) Co., Ltd. | LZA | Class I | 2022-05-23 |
| K220507 | 3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large | 3M Company | PZW | Class II | 2022-05-23 |
| K213800 | Artiglass NRFitTM Tip L.O.R. Glass Syringes | Artiglass Srl | QEH | Class II | 2022-05-19 |
| K214120 | GSS610N21 Series Steam Sterilizer | Maquet GmbH | FLE | Class II | 2022-05-18 |
| K220211 | Nitrile Powder Free Examination Gloves | Hebei Kangxida Medical Technology Development Co., Ltd. | LZA | Class I | 2022-05-18 |
| K212408 | Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid) | Pt. Maja Agung Latexindo | LZA | Class I | 2022-05-18 |
| K220404 | STERRAD NX with ALLClear Technology | Advanced Sterilization Products, Inc. | MLR | Class II | 2022-05-16 |
| K210516 | Clicky Cross | Yomura Technologies, Inc. | FMG | Class II | 2022-05-16 |
| K220626 | Introcan Safety IV Catheter | B.Braun Medical, Inc. | FOZ | Class II | 2022-05-14 |
| K220491 | Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs | Hainan Asther Medical Equipment Co., Ltd. | LZC | Class I | 2022-05-14 |
| K220429 | Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile | One Glove Industrial Sdn Bhd | LZA | Class I | 2022-05-13 |
15,723 clearances in the General Hospital panel. Data: openFDA.