Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 19
- Latest Decision
- 2022-03-01
Clearances · page 12 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K210073 | Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo | Fresenius Kabi AG | FRN | Class II | 2022-03-01 |
| K210848 | Sure-Fine Insulin Syringes | Shina Med Corporation | FMF | Class II | 2022-03-01 |
| K211776 | Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) | Microlife Intellectual Property GmbH | FLL | Class II | 2022-03-01 |
| K212833 | Disposable Nitrile Examination Gloves | Chifeng Huawei Medical Science&Technology Co., Ltd. | LZA | Class I | 2022-02-28 |
| K213084 | Ear Thermometer, Model ET005, ET008, ET009 | Guangzhou Berrcom Medical Device Co., Ltd. | FLL | Class II | 2022-02-25 |
| K212949 | Sterile Syringe with Safety Needle for Single Use, Sterile Syringe with Needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use, Sterile Needle for Single Use | Henan Nursecare Biotechnology Co., Ltd. | MEG | Class II | 2022-02-24 |
| K213991 | Enbio S | Enbio Group AG | FLE | Class II | 2022-02-22 |
| K213548 | Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy | Mercator Medical (Thailand), Ltd. | LZA | Class I | 2022-02-21 |
| K213500 | TMG Nitrile Powder Free Examination Glove | Thai Medical Glove Co., Ltd. | LZA | Class I | 2022-02-21 |
| K220232 | Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange | Megine Industries Sdn Bhd | LZA | Class I | 2022-02-20 |
| K213600 | Medical nitrile examination gloves (Model: SH001) | Jiangxi Sanhao Medical Instruments Co.,Ltd | LZA | Class I | 2022-02-19 |
| K213912 | Disposable Medical Nitrile Examination Gloves | Jiangsu Maolin Medical Technology Co., Ltd. | LZA | Class I | 2022-02-19 |
| K212998 | Powder Free Nitrile Examination Gloves (White, Blue and Black) | Alcatron Gloves Factory | LZA | Class I | 2022-02-19 |
| K213286 | EONS Nitrile Examination Gloves Powder Free | Eons Gloves (Thailand) Co., Ltd. | LZA | Class I | 2022-02-19 |
| K214110 | Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs | Mah Sing Healthcare Sdn. Bhd. | LZA | Class I | 2022-02-19 |
| K213688 | Nitrile Examination Gloves (Model: ZMG1351) | Wuhan Zonsen Medical Products Co., Ltd. | LZA | Class I | 2022-02-18 |
| K213306 | Powder Free Nitrile Examination Gloves, Blue,Test For Use With Chemotherapy Drugs | Zibo Sinocare Plastic Products Co., Ltd. | LZA | Class I | 2022-02-18 |
| K213440 | Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs | Luliang Hongruida Health Protection Technology Co., Ltd. | LZA | Class I | 2022-02-18 |
| K213634 | Vinyl/Nitrile Blend Exam Glove | Dezhou Hengchang Medical Technology Co., Ltd. | LYZ | Class I | 2022-02-18 |
| K213079 | Ear Thermometer, Model ET001 | Guangzhou Berrcom Medical Device Co., Ltd. | FLL | Class II | 2022-02-18 |
| K212586 | Amazing+ | Amazing Rubber Products Pvt, Ltd. | LZA | Class I | 2022-02-17 |
| K213107 | Powder Free Blue Nitrile Examination Gloves | Novid Ppe Sdn. Bhd. | LZA | Class I | 2022-02-17 |
| K212824 | Bluezone Model RX-450 Air Purifier | Bluezone Products, Inc. | FRA | Class II | 2022-02-17 |
| K213625 | Vinyl Examination Gloves | Dezhou Hengchang Medical Technology Co., Ltd. | LYZ | Class I | 2022-02-17 |
| K210864 | Safety Pen Needle | Sandstone Medical (Suzhou), Inc. | FMI | Class II | 2022-02-17 |
| K210229 | Sterile Auto-Disable Syringes with/without Needle for Single Use | Zhejiang Kangkang Medical-Devices Co., Ltd. | MEG | Class II | 2022-02-15 |
| K212011 | Vinyl Powder Free Examination Glove | Top Glove Vietnam Company Limited | LYZ | Class I | 2022-02-14 |
| K213664 | B. Braun Introcan Safety 2 IV Catheter | B.Braun Medical, Inc. | FOZ | Class II | 2022-02-11 |
| K213632 | Instylla Delivery Kit | Instylla, Inc. | FMF | Class II | 2022-02-10 |
| K213058 | O'Star Nitrile Examination Gloves Powder Free | Star Investment and Trade Joint Stock Company | LZA | Class I | 2022-02-08 |
| K213082 | Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311 | Guangzhou Berrcom Medical Device Co., Ltd. | FLL | Class II | 2022-01-28 |
| K212598 | iHealth infrared Ear thermometer PT5 | Andon Health Co, Ltd. | FLL | Class II | 2022-01-28 |
| K213142 | Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, 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 | 2022-01-28 |
| K213325 | Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs | Anhui Xinyisheng Medical Technology Co.,Ltd | LZC | Class I | 2022-01-28 |
| K211210 | Sterile Auto-Disable Syringes with/without Needle for Single Use | Azur Medical Company, Inc. | FMF | Class II | 2022-01-27 |
| K211482 | Disposable Syringe with Needle | Shandong Qinkai Medical Industry Co., Ltd. | FMF | Class II | 2022-01-24 |
| K210810 | Steiking Packaging for Medical Devices | Wipak OY | FRG | Class II | 2022-01-23 |
| K210463 | Thermoplastic Elastomer (TPE) Hybrid Examination Glove | Xuzhou Full Sun Medical Products , Ltd. | LZA | Class I | 2022-01-23 |
| K211752 | Infrared Thermometer | Beijing Choice Electronic Technology Co., Ltd. | FLL | Class II | 2022-01-21 |
| K211864 | Powder Free Nitrile Patient Examination Gloves, Blue Color | Siyang Jaysun Medtech Co., Ltd. | LZA | Class I | 2022-01-21 |
| K213044 | Nitrile Examination Gloves | Jiangsu Huayuan Medical Technology Co., Ltd. | LZA | Class I | 2022-01-21 |
| K213412 | VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM | Steris Corparation | JOJ | Class II | 2022-01-21 |
| K212592 | Gas-Chex Indicator | Propper Manufacturing Co., Inc. | JOJ | Class II | 2022-01-20 |
| K213075 | Goody Gloves, Wincare, TBG Gloves | Thai Rubber Gloves Co., Ltd. | LZA | Class I | 2022-01-20 |
| K211003 | SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove | Showa Best Glove, Inc. | LZA | Class I | 2022-01-19 |
| K213227 | Powder free Nitrile Examination Glove-(Test for use with Chemotherapy Drugs) | Uweport, LLC | LZA | Class I | 2022-01-19 |
| K212842 | Microvolume Luer Access Device | B.Braun Medical, Inc. | FPA | Class II | 2022-01-18 |
| K201044 | CHIRANA Insulin Syringes | Chirana T. Injecta | FMF | Class II | 2022-01-18 |
| K211360 | Disposable Nitrile Powder Free Examination Gloves (Non-sterile) | Pt. Universal Gloves | LZA | Class I | 2022-01-15 |
| K213859 | Stronghold Group Nitrile Examination Glove, Powder Free | Stronghold Group, LLC | LZA | Class I | 2022-01-13 |
| K212735 | Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) | Xingyu Medical Tech Co., Ltd. | LZA | Class I | 2022-01-11 |
| K213168 | Medical Examination Gloves | Shandong Huiwosheng Health Technology Co.,Ltd | LZA | Class I | 2022-01-11 |
| K211666 | Powder Free Nitrile Examination Gloves, Blue Chemotest | Careglove Global Sdn. Bhd. | LZA | Class I | 2022-01-09 |
| K212801 | Powder free nitrile examination glove- black, non sterile | Hong Seng Gloves Sdn Bhd | LZA | Class I | 2022-01-09 |
| K213262 | CELERITY HP Chemical Indicator | STERIS Corporation | QKM | Class II | 2022-01-07 |
| K211716 | DropSafe Safety Pen Needles | Htl Strefa SA | FMI | Class II | 2022-01-07 |
| K210564 | Infrared Thermometer | Alicn Medical Shenzhen, Inc. | FLL | Class II | 2022-01-07 |
| K212797 | iPrime Viscodelivery System | Glaukos | MRH | Class II | 2022-01-06 |
| K212847 | Penta Glove | Pentavest Holdings Sdn Bhd | LZA | Class I | 2022-01-06 |
| K213019 | Vinyl Exam Gloves | Hebei Astro Medical Supply Co., Ltd. | LYZ | Class I | 2022-01-05 |
| K213080 | T-Edge 10, T-Edge 11 | Tuttnauer , Ltd. | FLE | Class II | 2022-01-04 |
| K213187 | Disposable Nitrile Medical Powder-free Glove | Fujian Chunhui Medical Supply Co., Ltd. | LZA | Class I | 2022-01-03 |
| K203177 | Sterisystem Dry-Base Instrument Tray | O&M Halyard, Inc. | KCT | Class II | 2022-01-02 |
| K212834 | Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs) | Siyang Threeguard Medical Supplies Co., Ltd. | LZA | Class I | 2021-12-30 |
| K213073 | Goody Gloves, Wincare, TBG Gloves | Thai Rubber Gloves Co., Ltd. | LYY | Class I | 2021-12-29 |
| K213016 | ATM Glove | Phu Duc Huy Production Trading Services Corporation | LZA | Class I | 2021-12-28 |
| K213209 | EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device | K1 Medical, LLC | KCT | Class II | 2021-12-28 |
| K212716 | Dermoaroma Disposable Nitrile Examination Glove | Chuzhou Harmony Gloves Medical Technology Co.,Ltd | LZA | Class I | 2021-12-27 |
| K212921 | Nitrile Examination Golves Powder Free | Jiangsu Standard Health Co.,Ltd | LZA | Class I | 2021-12-24 |
| K212436 | NBR Synthetic Nitrile Examination Gloves | Shandong Langtai International Trade Co., Ltd. | LYZ | Class I | 2021-12-23 |
| K211022 | Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims. | Central Medicare Sdn Bhd | LZA | Class I | 2021-12-22 |
| K213144 | Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors | Shen Wei USA, Inc. | LYZ | Class I | 2021-12-22 |
| K212914 | Glovmaster Nitrile Examination Glove Powder Free | Glovmaster Sdn. Bhd. | LZA | Class I | 2021-12-22 |
| K212613 | Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue) | Koon Seng Sdn Bhd | LZA | Class I | 2021-12-21 |
| K213006 | Vinyl Examination Gloves | Taian Hengchang Medical Technology Co., Ltd. | LYZ | Class I | 2021-12-21 |
| K211865 | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) | Liao Ning Shangwei Medical Products Co., Ltd. | LYZ | Class I | 2021-12-20 |
| K213076 | AspenMed+ | Aspen Glove Sdn. Bhd. | LZC | Class I | 2021-12-20 |
| K203468 | TCAT TKA Instrument Tray | THINK Surgical, Inc. | KCT | Class II | 2021-12-20 |
| K212932 | Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray | Nobel Biocare Services AG | KCT | Class II | 2021-12-18 |
| K213051 | Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) | Yunnan Huazhiyuan Medical Technology Co., Ltd. | LZA | Class I | 2021-12-18 |
| K211457 | Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) | Ammex Corporation | LZA | Class I | 2021-12-18 |
| K213048 | Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) | Huayuan Medical Technology(Shangqiu) Co., Ltd. | LZA | Class I | 2021-12-18 |
| K211624 | USA Gloves Nitrile Powder Free Exam Gloves | Usa Gloves | LZA | Class I | 2021-12-18 |
| K210914 | Sterile Syringe for Single Use | Jiangsu Suyun Medical Material Co., Ltd. | FMF | Class II | 2021-12-17 |
| K211209 | Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves | Hycare International Co., Ltd. | LZA | Class I | 2021-12-17 |
| K200943 | Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System | Circa Scientific, LLC | FLL | Class II | 2021-12-17 |
| K213407 | UltiCare Disposable Pen Needles | Ultimed Incorporated | FMI | Class II | 2021-12-16 |
| K212898 | Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With Chemotherapy Drugs | Rimba Glove Snd Bhd | LZA | Class I | 2021-12-16 |
| K212645 | AT | At Glove Engineering Sdn. Bhd | LZA | Class I | 2021-12-16 |
| K212919 | Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) | Jiujiang Taixin Technology Co., Ltd. | LZA | Class I | 2021-12-15 |
| K200176 | FREEDOM Integrated Syringe Infusion System | Repro-Med Systems, Inc. Dba Koru Medical Systems | FRN | Class II | 2021-12-15 |
| K200932 | Blood Collection Needles | Vacutest Kima Srl | FMI | Class II | 2021-12-14 |
| K213029 | Nitrile Examination Gloves (Powder free, Blue) | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | LZA | Class I | 2021-12-14 |
| K210481 | Instant 20s Indicator | True Indicating, LLC | MTC | Class II | 2021-12-14 |
| K210388 | Non Sterile Nitrile Powder Free Examination Gloves Blue, Green and Black color | Mexpo International, Inc. | LZA | Class I | 2021-12-13 |
| K213176 | Disposable Nitrile Powder-Free Examination Gloves | Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd. | LZA | Class I | 2021-12-13 |
| K212924 | Nitrile Examination Gloves | Shanxi Nacosa Medical Technology Co.,Ltd | LZA | Class I | 2021-12-13 |
| K212085 | Siam NTD+ Nitrile Powder-Free Examination gloves | Siam Ntd Corporation Co., Ltd. | LZA | Class I | 2021-12-11 |
| K212840 | Nitrile Gloves (Model: NE01) | Byd Auto Industry Company Limited | LZA | Class I | 2021-12-11 |
| K212182 | Iconic Nitrile Glove | Iconic Medicare Sdn Bhd | LZA | Class I | 2021-12-11 |
15,723 clearances in the General Hospital panel. Data: openFDA.