Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 28
- Latest Decision
- 2023-04-16
Clearances · page 8 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K221974 | EpiFinder | Omeq Medical , Ltd. | FMF | Class II | 2023-04-16 |
| K223018 | OSPREY PERIPHERAL IV Catheter System | Skydance Vascular, Inc. | FOZ | Class II | 2023-04-14 |
| K220345 | STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | Plasmapp Co,., Ltd. | MLR | Class II | 2023-04-14 |
| K220312 | Polyfusion IV Administration Sets | Poly Medicure Limited | FPA | Class II | 2023-04-12 |
| K223088 | BD SmartSite Needle-Free Connector | Care Fusion | FPA | Class II | 2023-04-07 |
| K222739 | Disposable Insulin Pen Needle | Hantech Medical Device Co., Ltd. | FMI | Class II | 2023-04-06 |
| K230022 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library | Baxter Healthcare Corporation | FRN | Class II | 2023-03-31 |
| K230041 | Spectrum IQ Infusion System with Dose IQ Safety Software | Baxter Healthcare Corporation | FRN | Class II | 2023-03-31 |
| K220088 | Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Professional Latex Sdn Bhd | LZA | Class I | 2023-03-30 |
| DEN210039 | SNOO Smart Sleeper | Happiest Baby, Inc. | QTG | Class II | 2023-03-30 |
| K230582 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | STERIS Corporation | MED | Class II | 2023-03-28 |
| K230046 | Vinyl examination gloves | Guangdong Kingfa Sci. & Tech.Co., Ltd. | LYZ | Class I | 2023-03-25 |
| K220644 | Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs | Yty Industry (Manjung) Sdn Bhd | LZA | Class I | 2023-03-25 |
| K223076 | BD Texium Closed Male Luer | Care Fusion | ONB | Class II | 2023-03-24 |
| K230002 | Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs | Mah Sing Healthcare Sdn. Bhd. | LZA | Class I | 2023-03-24 |
| K223895 | Disposable Medical Nitrile Examination Gloves | Hebei Titans Hongsen Medical Technology Co., Ltd. | LZA | Class I | 2023-03-23 |
| K212207 | Sterile Hypodermic Syringe for Single Use | Shandong Weigao Group Medical Polymer Co., Ltd. | FMF | Class II | 2023-03-23 |
| K222151 | Sterilization Wrap | Kenpax International Limited | FRG | Class II | 2023-03-23 |
| K223672 | Instrument Case P1340904 | Cochlear | KCT | Class II | 2023-03-21 |
| K222417 | Shina Safety Needle | Shina Corporation | FMI | Class II | 2023-03-20 |
| K222813 | Nitrile Examination Gloves | Ecoglove Medical Manufacturing Company Limited | LZA | Class I | 2023-03-16 |
| K223375 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate. | Kossan International Sdn Bhd3 | LZA | Class I | 2023-03-15 |
| K223102 | Tegamen Nitrile Examination Gloves | M/S Tegamen Safety Products Private Limited | LZA | Class I | 2023-03-15 |
| K223175 | lntravascular Administration Sets with Stopcock and Manifold | Baxter Healthcare Corporation | FMG | Class II | 2023-03-10 |
| K222718 | Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | LHI | Class II | 2023-03-10 |
| K213744 | Avoset Infusion Pump System | Eitan Medical , Ltd. | FRN | Class II | 2023-03-10 |
| K222672 | Disposable Insulin Syringe | Hantech Medical Device Co., Ltd. | FMF | Class II | 2023-03-06 |
| K223453 | Insulin Syringe | Promisemed Hangzhou Meditech Co., Ltd. | FMF | Class II | 2023-03-02 |
| K221641 | Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB) | Terragene S.A. | FRC | Class II | 2023-02-28 |
| K221702 | CompuFlo Epidural Computer Controlled Anesthesia System | Milestone Scientific, Inc. | FMF | Class II | 2023-02-25 |
| K221629 | Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters) | Covidien | GAG | Class II | 2023-02-22 |
| K223298 | Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) | Shandong Intco Medical Products Co, Ltd. | LYY | Class I | 2023-02-22 |
| K222588 | Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1 | Iweecare Co., Ltd. | FLL | Class II | 2023-02-17 |
| K220276 | Infrared Thermometer TET-351 | Truly Instrument Limited | FLL | Class II | 2023-02-17 |
| K221513 | Equashield Closed System Transfer Device | Equashield Medical , Ltd. | ONB | Class II | 2023-02-17 |
| K223327 | Sterile Aesthetic Cannula and Hypodermic Needle | Shanghai Kindly Enterprise Development Group Co., Ltd. | FMI | Class II | 2023-02-16 |
| K222622 | Disposable Infusion Bag for Parenteral Nutrition | Beijing L&Z Medical Technology Development Co., Ltd. | KPE | Class II | 2023-02-16 |
| K222271 | Verisafe Safety sterile needles | Promisemed Hangzhou Meditech Co., Ltd. | FMI | Class II | 2023-02-15 |
| K221875 | Sterilization Pouch and Roll | Qianjiang Kingphar Medical Packaging & Printing Co., Ltd. | FRG | Class II | 2023-02-13 |
| K212635 | Sofjec | Hwajin Medical Co., Ltd. | FMF | Class II | 2023-02-13 |
| K223859 | Rhino Non-sterile Powder-Free Nitrile Exam Glove Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl | Rhino Health, Inc. | LZA | Class I | 2023-02-13 |
| K221474 | PRIMUS Healthcare Sterilizer (Model PSS11-HC) | Primus Sterilizer Company, LLC | FLE | Class II | 2023-02-10 |
| K222129 | Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim, Nitrile Examination Powder Free Glove, Black Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim | Top Glove Medical (Thailand) Co., Ltd. | LZA | Class I | 2023-02-10 |
| K220657 | Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001) | Zhejiang Rongsheng Industrial Co., Ltd. | FLL | Class II | 2023-02-10 |
| K223678 | Sterile Syringes for Single Use | Shanghai Kindly Enterprise Development Group Co., Ltd. | FMF | Class II | 2023-02-09 |
| K223559 | Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) | Nephron Pharmaceuticals Corporation | LZA | Class I | 2023-02-09 |
| K203211 | Insulin syringe with integrated needle DL | Dlp Medical Products, Corp. | FMF | Class II | 2023-02-09 |
| K223444 | Powder Free Blue Nitrile Examination Glove | S&S Glove Corporation | LZA | Class I | 2023-02-06 |
| K221980 | Disposable Powder Free Vinyl Examination Gloves, Beige/Clear | Ever Global (Vietnam) Enterprise Corporation | LYZ | Class I | 2023-02-06 |
| K223648 | Cook® Spectrum® 2 MRC Central Venous Catheter | Cook Advanced Technologies | FOZ | Class II | 2023-02-03 |
| K213545 | Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869 | Steelco S.P.A. | FLE | Class II | 2023-02-02 |
| 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) | Semperit Investments Asia Pte , Ltd. | LZA | Class I | 2023-01-27 |
| K223415 | Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Mah Sing Healthcare Sdn. Bhd. | LZA | Class I | 2023-01-26 |
| K220114 | PowerPAK Syringe | Vault Paragon Group, Inc. | MEG | Class II | 2023-01-25 |
| K222531 | Synthetic Polymer Glove - Polyethylene (Black) | Ur Industry Sdn Bhd | LZA | Class I | 2023-01-22 |
| K214077 | Digital Thermometer, Model: DT007, DT008 | Guangzhou Berrcom Medical Device Co., Ltd. | FLL | Class II | 2023-01-20 |
| K222889 | FlowArt® Needle-Free Split Septum Valve | Asset Medikal Tasarim San Tic As. | FPA | Class II | 2023-01-20 |
| K203792 | Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle | Pikdare Spa | FMI | Class II | 2023-01-20 |
| K223250 | Disposable Nitrile Examination Glove | Yangzhou Saraguard Medical Supplies Co., Ltd. | LZA | Class I | 2023-01-19 |
| K223748 | Nitrile Exam Gloves (Chemotherapy Drug Tested) | Us Medical Glove Company, LLC | LZA | Class I | 2023-01-13 |
| K223221 | Non-Sterile Powder Free Nitrile Examination Gloves | Dynacare Sdn Bhd | LZA | Class I | 2023-01-13 |
| K222181 | Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate | Iconic Medicare Sdn Bhd | LZA | Class I | 2023-01-11 |
| K221379 | Steriking LT-Blueline Pouches with Tyvek | Wipak OY | FRG | Class II | 2023-01-04 |
| K222907 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Rmkh Glove (Cambodia) Co., Ltd. | LZA | Class I | 2023-01-04 |
| K214041 | Aesculap AICON Container | Aesculap, Inc. | KCT | Class II | 2022-12-30 |
| K221981 | SafeR Syringe and SafeR Sting | Roncadelle Operations Srl | MEG | Class II | 2022-12-29 |
| K223286 | BD AutoShield Duo Pen Needle | Becton, Dickinson and Company | FMI | Class II | 2022-12-28 |
| K221377 | SteriKing LT-Blueline Pouches with Tyvek | Wipak OY | FRG | Class II | 2022-12-22 |
| K221603 | Kangaroo OMNI Enteral Feeding Pump (385400 );Kangaroo OMNI Feeding Set 500ml (B5FD );Kangaroo OMNI ENtelliSet 500ml (E5FD );Kangaroo OMNI Feeding Set 1000ml (B10FD );Kangaroo OMNI ENtelliSet 1000ml (E10FD );Kangaroo OMNI ENPlus Spike Set (BSPFD );Kangaroo OMNI ENtelliSet ENPlus Spike ( ESPFD );Kangaroo OMNI Feeding Set 500ml with Flush Bag ( B5FF);Kangaroo OMNI ENtelliSet 500ml with Flush Bag (E5FF);Kangaroo OMNI Feeding Set 1000ml with Flush Bag ( E10FF );Kangaroo OMNI | Cardinal Health, LLC | LZH | Class II | 2022-12-20 |
| K221039 | Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y | Shenzhen AOJ Medical Technology Co., Ltd. | FLL | Class II | 2022-12-20 |
| K222608 | Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS | Tuttnauer , Ltd. | FLE | Class II | 2022-12-16 |
| K223334 | Sterile Hypodermic Needles for Single Use | Zhejiang Kindly Medical Devices Co., Ltd. | FMI | Class II | 2022-12-16 |
| K222892 | Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs | Grand Work Plastic Products Co., Ltd. | LZA | Class I | 2022-12-15 |
| K221800 | Infrared Thermometer (Model: Y20001, Y20002) | Zhangzhou Easepal Medical Science and Technology Co., Ltd. | FLL | Class II | 2022-12-14 |
| K222527 | Nitrile Patient Examination Glove | Pingan Medical Products Co., Ltd. | LZA | Class I | 2022-12-14 |
| K214004 | CCBIO ASCPO Needle | Cc Biotechnology Corporation | FMI | Class II | 2022-12-13 |
| K222733 | Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug) | Inner Mongolia Boming Medical Supplies Co., Ltd. | LZA | Class I | 2022-12-11 |
| K213054 | Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe | Medline Industries, Inc. | FMF | Class II | 2022-12-09 |
| K211800 | Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer | Quality IN Flow , Ltd. | LGZ | Class II | 2022-12-08 |
| K223281 | Disposable Nitrile Examination Glove | Anhui Kindguard Medical Supplies Technology Co., Ltd. | LZA | Class I | 2022-12-07 |
| K220772 | HydroMID 4F Single Lumen Midline Catheter | Access Vascular, Inc. | FOZ | Class II | 2022-12-07 |
| K221626 | Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | LZA | Class I | 2022-12-07 |
| K222385 | Bifurcated Needle | Anhui Tiankang Medical Technology Co., Ltd. | SCL | Class II | 2022-12-06 |
| K222689 | Mallya Injection Pen Adapter (Mallya® for Solostar®) | Biocorp Production | QOG | Class II | 2022-12-05 |
| K222681 | Altaviz Needle Kit | Altaviz, LLC | FMI | Class II | 2022-12-05 |
| K222137 | OK Plus Indicator | Propper Manufacturing Co., Inc. | JOJ | Class II | 2022-12-05 |
| K223004 | Disposable Nitrile Examination Gloves | Jiangxi Handspro Products Solutions Co., Ltd. | LZA | Class I | 2022-12-04 |
| K222815 | Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl | Zibo Lanhua Medical Packaging Material Co., Ltd. | LZA | Class I | 2022-12-04 |
| K222720 | Blue Nitrile Powder Free Patient Examination Glove, Non Sterile | Safeskin Retailing (Hk) Limited | LZA | Class I | 2022-12-03 |
| K222713 | White Nitrile Powder Free Patient Examination Glove, Non Sterile | Safeskin Retailing (Hk) Limited | LZA | Class I | 2022-12-03 |
| K222715 | Black Nitrile Powder Free Patient Examination Glove, Non Sterile | Safeskin Retailing (Hk) Limited | LZA | Class I | 2022-12-03 |
| K223353 | DropSafeTM SicuraTM | Pikdare Spa | FMI | Class II | 2022-12-02 |
| K220778 | Chemical Indicator for Steam | True Indicating, LLC | JOJ | Class II | 2022-12-02 |
| K221747 | Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs | Fitone Latex Products Co., Ltd. Guangdong | LZA | Class I | 2022-12-01 |
| K221082 | Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl | Rhino Health, Inc. | LZA | Class I | 2022-11-30 |
| K223328 | Purgo | Aeroclean Technologies, Inc. | FRA | Class II | 2022-11-30 |
| K211050 | Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304 | Jkh Health Co., Ltd. | FLL | Class II | 2022-11-28 |
| K222612 | Powder-Free Latex examination gloves | Guangdong Kingfa Sci. & Tech.Co., Ltd. | LYY | Class I | 2022-11-25 |
| K222452 | Disposable Automatically Retractable Safety Syringes (with detachable needle) | Shantou Wealy Medical Instrument Co.,Ltd | MEG | Class II | 2022-11-23 |
| K201460 | Closed System Transfer Device | Shinva Ande Healthcare Apparatus Co., Ltd. | ONB | Class II | 2022-11-23 |
15,723 clearances in the General Hospital panel. Data: openFDA.