Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 29
- Latest Decision
- 2022-05-13
Clearances · page 11 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K213203 | Provena(TM) Midline Catheter | C.R. Bard, Inc. | PND | Class II | 2022-05-13 |
| K213535 | Sterile Safety Hypodermic Needles for Single Use | Zhejiang Kangkang Medical-Devices Co., Ltd. | FMI | Class II | 2022-05-13 |
| K213811 | Sterile Hypodermic Syringes for Single Use | Berpu Medical Technology Co., Ltd. | FMF | Class II | 2022-05-12 |
| K220118 | Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves | Kl-Kepong Rubber Products Sdn. Bhd. | LZA | Class I | 2022-05-12 |
| K210937 | Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241 | Alicn Medical Shenzhen, Inc. | FLL | Class II | 2022-05-12 |
| K220442 | Synguard Nitrile Exam Glove | Tianjin Aoshang Outdoor Equipment Co., Ltd. | LZA | Class I | 2022-05-12 |
| K220250 | Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs | Grand Work Plastic Products Co., Ltd. | LZA | Class I | 2022-05-11 |
| K220428 | Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile | One Glove Industrial Sdn Bhd | LZA | Class I | 2022-05-10 |
| K220427 | White Nitrile Powder-Free Patient Examination Glove, Non Sterile | One Glove Industrial Sdn Bhd | LZA | Class I | 2022-05-10 |
| K213004 | Needle Free Connector | Medcaptain Life Science Co., Ltd. | FPA | Class II | 2022-05-10 |
| K212346 | Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618 | Shenzhen Pango Medical Electronics Co., Ltd. | FLL | Class II | 2022-05-05 |
| K210565 | Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711 | Alicn Medical Shenzhen, Inc. | FLL | Class II | 2022-05-05 |
| K221016 | Steriking Packaging for Medical Devices | Wipak OY | FRG | Class II | 2022-05-05 |
| K212257 | Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311 | Alicn Medical Shenzhen, Inc. | FLL | Class II | 2022-05-04 |
| K213550 | HydroPICC 5F Dual Lumen Catheter | Access Vascular, Inc. | LJS | Class II | 2022-05-04 |
| K212064 | Orchid Safety Release Valve(TM) | Linear Health Sciences, LLC | QOI | Class II | 2022-05-03 |
| K220791 | Surgical and Prosthetic Trays | Dentsply Sirona | KCT | Class II | 2022-05-03 |
| K214045 | FreedomEdge Syringe Infusion System | Repro-Medical System, Inc., Dba Koru Medical Systems | FRN | Class II | 2022-04-29 |
| K212711 | SteriTite Container System with MediTray Products | Case Medical, Inc. | KCT | Class II | 2022-04-29 |
| K220417 | Spectrum IQ Infusion System with Dose IQ Safety Software | Baxter Healthcare Corporation | FRN | Class II | 2022-04-29 |
| K220695 | Elite Biomedical Solutions Dose Request Cord | Elite Biomedical Solutions | MRZ | Class II | 2022-04-29 |
| K212514 | Safety Pen Needle for Single Use, Insulin Pen Needles | Berpu Medical Technology Co., Ltd. | FMI | Class II | 2022-04-29 |
| K213077 | Automatically Retractable Safety Syringe | Zhejiang Lingyang Medical Apparatus Co., Ltd. | MEG | Class II | 2022-04-27 |
| K213040 | 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 | 2022-04-27 |
| K213775 | Glovatex White Latex Gloves, Glovanil Blue Nitrile Gloves | Avecena Gloves Sdn Bhd | LYY | Class I | 2022-04-24 |
| K212530 | IVX Fluid Transfer Set | Omnicell, Inc. | LHI | Class II | 2022-04-24 |
| K220382 | Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) - Blue/Black/Purple | Jiangsu Bytech Medical Supplies Co., Ltd. | LZA | Class I | 2022-04-21 |
| K213681 | Ivory Glove Powder-Free Nitrile Examination Gloves | Ivory Gloves Sdn. Bhd. | LZA | Class I | 2022-04-21 |
| K212022 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | 3M Company | QKM | Class II | 2022-04-20 |
| K213408 | BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free | Meditech Gloves Sdn Bhd | LZA | Class I | 2022-04-17 |
| K212677 | aboNT SYRINGE | Nipro Medical Corporation | FMF | Class II | 2022-04-15 |
| K220561 | Disposable Medical Nitrile Examination Gloves | Nanjing Universal Medical Equipment Co., Ltd. | LZA | Class I | 2022-04-14 |
| K220375 | Intercept Free, Nitrile Two Toned White/Green, Textured Fingertips, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Examination Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit) | Summit Glove, Inc. | LZA | Class I | 2022-04-13 |
| K220373 | Get-A-Grip/Rescue-Grip, Nitrile Two Toned Black/Green, Diamond Grip Technology, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit) | Summit Glove, Inc. | LZA | Class I | 2022-04-13 |
| K214051 | Neodent Implant System-Helix NGM Compact Surgical Kit Cases | JJGC Indústria e Comércio de Materiais Dentários S.A. | KCT | Class II | 2022-04-13 |
| K214075 | Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder) | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | FMI | Class II | 2022-04-12 |
| K213296 | Anprolene SteriTest RRBI | Andersen Sterilizers, Inc. | FRC | Class II | 2022-04-12 |
| K220209 | Powder Free Nitrile Examination Glove, Non-sterile (Blue) | Ksg Medicare Sdn. Bhd. | LZA | Class I | 2022-04-11 |
| K213437 | 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 | 2022-04-11 |
| K220121 | Non Sterile Nitrile Powder Free Examination Gloves Blue,Green, and Black | Aamedix Glove Sdn Bhd | LZA | Class I | 2022-04-11 |
| K212929 | Nitrile Examination Gloves | Watchtower Ppe Supplies, Inc. | LZA | Class I | 2022-04-09 |
| K220401 | Pink Powder Free Nitrile Examination Glove With Bubblegum Scented, Chemotherapy Drugs And Fentanyl Test Claim | Riverstone Resources Sdn Bhd | LZA | Class I | 2022-04-09 |
| K213633 | ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler | Ethicon Endo-Surgery, LLC | GAG | Class II | 2022-04-08 |
| K213509 | Latex Examination Gloves, Powder Free | Shandong Intco Medical Products Co, Ltd. | LYY | Class I | 2022-04-08 |
| K212309 | Non-sterile, Powder-Free Latex Examination Glove | Sri Trang Gloves (Thailand) Public Company Limited | LYY | Class I | 2022-04-08 |
| K210714 | Extended Reservoir | Medtronic Minimed, Inc. | LZG | Class II | 2022-04-06 |
| K213809 | 3M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M Attest Auto-reader, 3M Attest Mini Auto-reader | 3M Company | FRC | Class II | 2022-04-06 |
| K213560 | Verifine Safety Syringe with Fixed Needle | Promisemed Hangzhou Meditech Co., Ltd. | FMF | Class II | 2022-04-05 |
| K213011 | Infrared Thermometer (model: E201) | Bioland Technology, Ltd. | FLL | Class II | 2022-04-05 |
| K200946 | Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241) | Taidoc Technology Corporation | FLL | Class II | 2022-04-05 |
| K213746 | Digital thermometer, Model DT101, DT102 | Guangzhou Berrcom Medical Device Co., Ltd. | FLL | Class II | 2022-04-05 |
| K213604 | ELAZ Nitrile Powder Free Examination Glove | Protect Gloves Co., Ltd. | LZA | Class I | 2022-04-03 |
| K220066 | Medical Nitrile Examination Gloves | Hunan Zhenheyikang Medical Instrument Co., Ltd. | LZA | Class I | 2022-04-03 |
| K220343 | Nitrile Examination Gloves | Nb Medical Co., Ltd. | LZA | Class I | 2022-04-02 |
| K220240 | Vinyl Co-Polymer Powder-free Examination Gloves, Black | Grand Work Plastic Products Co., Ltd. | LYZ | Class I | 2022-03-31 |
| K220584 | BD Cathena Safety IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | FOZ | Class II | 2022-03-31 |
| K214057 | STATIM 6000B Vacuum Autoclave | Scican , Ltd. | FLE | Class II | 2022-03-31 |
| K213843 | Nitrile Examination Gloves | Dong Tai City Huayi Gloves Co., Ltd. | LZA | Class I | 2022-03-31 |
| K220353 | Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs | Niujian Technology Co., Ltd. | LZC | Class I | 2022-03-31 |
| K213662 | Disposable nitrile rubber protective gloves (Tested for Use with Chemotherapy Drugs) | Taishan Weibang Medical Equipment Co., Ltd. | LZA | Class I | 2022-03-28 |
| K220229 | Powder Free Nitrile Examination Gloves, Orange | Shanxi Hongjin Plastic Technology Co., Ltd. | LZA | Class I | 2022-03-26 |
| K213729 | Clover Glove | Clover Glove Company Limited | LZA | Class I | 2022-03-26 |
| K220215 | Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with Chemotherapy Drugs, and the Opioid Fentanyl citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid (Blue) | Ksg Medicare Sdn. Bhd. | LZA | Class I | 2022-03-26 |
| K213848 | Medical nitrile examination gloves (Model: JL001) | Guangdong Jiali Pharmaceutical Co.,Ltd | LZA | Class I | 2022-03-25 |
| K202437 | Infusion Sets for Single Use | Jiangsu Suyun Medical Materials Co., Ltd. | FPA | Class II | 2022-03-25 |
| K210037 | Pluski Safe 1 Safety IV Catheter | Mediplus (India) Limited | FOZ | Class II | 2022-03-25 |
| K220354 | Disposable Medical Synthetic Nitrile Examination Gloves | Niujian Technology Co., Ltd. | LZA | Class I | 2022-03-24 |
| K212916 | Black Nitrile Powder Free Patient Examination Glove, Non Sterile | Rimba Glove Sdn Bhd | LZA | Class I | 2022-03-24 |
| K213616 | BD Surgiphor Antimicrobial Irrigation System | Becton, Dickinson and Company | FQH | Class II | 2022-03-23 |
| K213522 | AMSafe Pre-Filled Normal Saline Flush Syringe | Amsino International, Inc. | NGT | Class II | 2022-03-22 |
| K213678 | Powder Free Blue Nitrile Examination Gloves | Lienteh Technology Sdn Bhd | LZA | Class I | 2022-03-22 |
| K210171 | Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701) | Sichuan Youkede Medical Equipment Co.,Ltd | FLL | Class II | 2022-03-18 |
| K220228 | Powder Free Nitrile Examination Gloves, Blue and Violet Blue, Test For Use With Chemotherapy Drugs | Shandong Blue Sail Health Technology Co., Ltd. | LZA | Class I | 2022-03-18 |
| K220473 | CELERITY 20 HP Challenge Pack | Steris | FRC | Class II | 2022-03-18 |
| K213823 | Intera Refill Kit | Intera Oncology, Inc. | PTI | Class II | 2022-03-16 |
| K213121 | Disposable Nitrile Examination Glove | Jiangsu Cureguard Glove Co., Ltd. | LZA | Class I | 2022-03-15 |
| K213907 | CareGUARD Sterilization Wrap | Care Essentials Pty, Ltd. | FRG | Class II | 2022-03-14 |
| K203738 | Qitexio | Medex | FMF | Class II | 2022-03-14 |
| K212920 | Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use | Shandong Weigao Group Medical Polymer Co., Ltd. | FMF | Class II | 2022-03-11 |
| K213038 | Infrared Forehead Thermometer, model: HS-9802D | Jiaxing Shangjia Intelligence Technology Co., Ltd. | FLL | Class II | 2022-03-10 |
| K212148 | Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs | Ansell Healthcare Products, LLC | LZA | Class I | 2022-03-10 |
| K220133 | Sterilization Wraps | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | FRG | Class II | 2022-03-10 |
| K213373 | Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Smart Glove Corporation Sdn. Bhd. | LZA | Class I | 2022-03-10 |
| K213910 | Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs | Changzhou Universal Medical Equipment Co., Ltd. | LZC | Class I | 2022-03-10 |
| K212499 | BD Insulin Syringe (0.3mL) | Becton, Dickinson and Company | FMF | Class II | 2022-03-09 |
| K213851 | Disposable Medical Nitrile gloves | Guangdong Xingcan Brothers Medical Technology Co.,Ltd | LZA | Class I | 2022-03-09 |
| K211808 | Medcare Powder-Free Blue Nitrile Patient Examination Gloves | Dongguan Grinvald Technology Co., Ltd. | LZA | Class I | 2022-03-04 |
| K210330 | Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant | Wrp Asia Pacific Sdn. Bhd. | LZA | Class I | 2022-03-04 |
| K212281 | Surgical Trays | Dentsply Sirona, Inc. | KCT | Class II | 2022-03-04 |
| K210216 | Disposable Automatically Retractable Insulin Safety Syringe | Shantou Wealy Medical Instrument Co.,Ltd | MEG | Class II | 2022-03-04 |
| K213778 | IV Administration Set | B.Braun Medical, Inc. | FPA | Class II | 2022-03-03 |
| K210923 | Southern Implants Instrument Trays | Southern Implants (Pty), Ltd. | KCT | Class II | 2022-03-02 |
| K213457 | Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135 | Fort Defiance Industries, LLC | FLE | Class II | 2022-03-02 |
| K212652 | Sterile Syringe with Fixed Safety Needle for Single Use | Gemtier Medical (Shanghai), Inc. | MEG | Class II | 2022-03-02 |
| K213551 | Giraffe Omnibed Carestation CS1 | Datex Ohmeda, Inc. | FMT | Class II | 2022-03-02 |
| K213553 | Giraffe Incubator Carestation CS1 | Datex Ohmeda, Inc. | FMZ | Class II | 2022-03-02 |
| K210074 | Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable | Fresenius Kabi AG | FRN | Class II | 2022-03-01 |
| K212945 | Sterile Disposable Temperature Probe | Shenzhen Envisen Industry Co., Ltd. | FLL | Class II | 2022-03-01 |
| K211484 | Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles | Shinva Ande Healthcare Apparatus Co., Ltd. | MEG | Class II | 2022-03-01 |
| K210075 | Vigilant Software Suite Vigilant Master Med | Fresenius Kabi AG | PHC | Class II | 2022-03-01 |
15,723 clearances in the General Hospital panel. Data: openFDA.