Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 20
- Latest Decision
- 2021-09-20
Clearances · page 14 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K211477 | Latex Examination Powder Free Gloves | Aspen Glove Sdn. Bhd. | LYY | Class I | 2021-09-20 |
| K210399 | Unifine SafeControl | Owen Mumford, Ltd. | FMI | Class II | 2021-09-17 |
| K211904 | Vinyl Glove | Jiangsu Dihong Industry and Trade Co., Ltd. | LYZ | Class I | 2021-09-17 |
| K211479 | Blue Nitrile Examination Glove Powder Free | Aspen Glove Sdn. Bhd. | LZA | Class I | 2021-09-16 |
| K203492 | Instrument tray, for semi-rigid ureteroscope | Olympus Winter & Ibe GmbH | KCT | Class II | 2021-09-15 |
| K210118 | INFRARED BODY THERMOMETER (Model: YK-001) | Longnan Renzhong Medical Equipment Co., Ltd. | FLL | Class II | 2021-09-15 |
| K210818 | TrueCare Biomedix Tamper Evident Cap | Us Infusion Inc. D/B/A Truecare Biomedix-USA | FMF | Class II | 2021-09-15 |
| K212009 | Disposable Nitrile Gloves | Jiangsu Shenglijie Safety Products Co., Ltd. | LZA | Class I | 2021-09-15 |
| K211464 | Nitta M&T Safety Box | Nitta M&T (Thailand) Co., Ltd. | MMK | Class II | 2021-09-14 |
| K210227 | Sterile syringe for single use with/without needle | Zhejiang Kangkang Medical-Devices Co., Ltd. | FMF | Class II | 2021-09-10 |
| K211352 | Electronic Thermometer (XHF2001, XHF2002) | Putian Hanjiang Huafeng Plastic Co., Ltd. | FLL | Class II | 2021-09-09 |
| K211242 | Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes | Promisemed Hangzhou Meditech Co., Ltd. | FMF | Class II | 2021-09-09 |
| K210712 | Verifine Mechanical Safety Insulin Syringe | Promisemed Hangzhou Meditech Co., Ltd. | FMF | Class II | 2021-09-08 |
| K210997 | PreferX Delivery System | Md3, LLC | FMF | Class II | 2021-09-07 |
| K211607 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate | STERIS Corporation | MED | Class II | 2021-09-07 |
| K212081 | 3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228 | 3M Company | JOJ | Class II | 2021-09-05 |
| K211583 | Infrared Thermometer, Model: HW-1 | Dongguan Simzo Electronic Technology Co., Ltd. | FLL | Class II | 2021-09-03 |
| K211778 | Nitrile Examination Gloves, Green/ Blue/ Black Color | Zhenjiang Suhui Latex Products Co., Ltd. | LZA | Class I | 2021-09-02 |
| K210868 | Nitrile Examination Gloves Powder Free (Blue) | Great Eco Glove Sdn. Bhd. | LZA | Class I | 2021-09-02 |
| K211673 | Disposable Medical Nitrile Gloves | Changzhou Yihua Sanitation Material Co., Ltd. | LZA | Class I | 2021-09-01 |
| K203636 | PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS, PTSW-AS, PTSM-15AS, PTSL-AS, PTMR-AS; Rectum Types: PT2252-AG, PTHP-AG, PTMQ-AG, PTSW-AG, PTSM-15AG, PTSL-AG, PTMR-AG | Jkh USA, LLC | FLL | Class II | 2021-08-31 |
| K211390 | Nitrile Blue Powder-free Examination Glove | Cardinal Health200, LLC | LZA | Class I | 2021-08-28 |
| K210047 | Stiletto Extended Dwell Catheter | Piper Access, LLC | PND | Class II | 2021-08-27 |
| K211634 | Hypodermic Needle-Pro EDGE Safety Device | Smiths Medical Asd, Inc. | FMI | Class II | 2021-08-26 |
| K210898 | Disposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue) | Tangshan Lanhai Medical Supplies Co., Ltd. | LZA | Class I | 2021-08-26 |
| K210991 | Disposable Sterile Syringe, Disposable Sterile Syringe with Needle | Guangdong Antmed Co., Ltd. | FMF | Class II | 2021-08-26 |
| K211500 | AMSCO 600 Medium Steam Sterilizer | STERIS Corporation | FLE | Class II | 2021-08-25 |
| K210897 | Disposable Nitrile Examination Gloves | Shandong DS Safety Technology Co., Ltd. | LZA | Class I | 2021-08-24 |
| K211515 | Nitrile Examination Gloves | Beijing Reagent Latex Products Co., Ltd. | LZA | Class I | 2021-08-24 |
| K211516 | Disposable Vinyl Nitrile Synthetic Gloves Powder Free | Tangshan Hongyun Plastic Products Co., Ltd. | LYZ | Class I | 2021-08-24 |
| K210464 | Auto Disable Syringe | Anhui Tiankang Medical Technology Co., Ltd. | FMF | Class II | 2021-08-24 |
| K203622 | Medical Gloves | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | LZA | Class I | 2021-08-20 |
| K211699 | Nitrile Exam Gloves, Powder Free, Blue | Hengchang (Dongying) Medical Technology Co., Ltd. | LZA | Class I | 2021-08-20 |
| K201857 | Powder Free Nitrile Examination Glove Black and Dual Color White-Blue | Careplus (M) Sdn Bhd | LZA | Class I | 2021-08-20 |
| K203705 | Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein) | Careplus (M) Sdn Bhd | LYY | Class I | 2021-08-20 |
| K211194 | Molekule Air Pro | Molekule, Inc. | FRA | Class II | 2021-08-20 |
| K210749 | Empty EVA Bag | Haemotronic S.P.A. | KPE | Class II | 2021-08-19 |
| K211319 | Purism Non-Sterile Powder Free Nitrile Examination Gloves | Dezhou Purism Medical Technology Co., Ltd. | LZA | Class I | 2021-08-19 |
| K211620 | Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less) | Shen Wei USA, Inc. | LYY | Class I | 2021-08-19 |
| K211708 | Disposable Medical Nitrile Gloves | Jiangsu Health-Peace Medical Technology Co., Ltd. | LZA | Class I | 2021-08-17 |
| K203236 | Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove | Rhino Health, Inc. | LZA | Class I | 2021-08-16 |
| K210381 | I.V. Administration Set | Bq Plus Medical Co., Ltd. | FPA | Class II | 2021-08-14 |
| K211860 | Powder Free Nitrile Patient Examination Gloves, Blue Color | Anhui Powerguard Technology Co., Ltd. | LZA | Class I | 2021-08-13 |
| K211575 | Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System | Insulet Corporation | LZG | Class II | 2021-08-13 |
| K202279 | Insignis Subcutaneous Needle Sets | Innovative Health Sciences, LLC | FPA | Class II | 2021-08-13 |
| K203643 | Sensatronic Reusable Temperature Probes | Sensatronic GmbH | FLL | Class II | 2021-08-11 |
| K202536 | Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, And Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate | Yty Industry (Manjung) Sdn Bhd | LZA | Class I | 2021-08-11 |
| K210730 | Nitrile Patient Examination Glove | American Performance Polymers, LLC | LZA | Class I | 2021-08-10 |
| K211540 | Edma Synthetic Nitrile Examination Gloves | Edma Group, LLC | LZA | Class I | 2021-08-09 |
| K211354 | Disposable Synthetic Vinyl Nitrile Examination Glove | Jiangsu Cureguard Glove Co., Ltd. | LYZ | Class I | 2021-08-08 |
| K210725 | Nitrile Patient Examination Glove | Pingan Medical Products Co., Ltd. | LZA | Class I | 2021-08-06 |
| K203305 | Tiger Reusable Sharps Container | International Marketing Specialists, Inc. | MMK | Class II | 2021-08-06 |
| K211608 | Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs) | Jiangsu Cureguard Glove Co., Ltd. | LZA | Class I | 2021-08-05 |
| K211434 | Nitrile Patient Examination Gloves | Zhangjiagang Huayuan Protective Equipment Co., Ltd. | LZA | Class I | 2021-08-05 |
| K211075 | Disposable Medical Nitrile Examination Gloves (Non-Sterile) | Jiangsu Cherish Medical Technology Co., Ltd. | LZA | Class I | 2021-08-05 |
| K211714 | Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy) | Hengchang (Dongying) Medical Technology Co., Ltd. | LZA | Class I | 2021-08-04 |
| K211758 | Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) | Hartalega NGC Sdn. Bhd. | OPC | Class I | 2021-08-03 |
| K211182 | H2H Powder Free Examination Blue Glove | Ntl Innovation Co., Ltd. | LZA | Class I | 2021-08-01 |
| K211264 | Disposable Nitrile Examination Gloves | Shenzhen Shiqiao Science and Technology Co., Ltd. | LZA | Class I | 2021-07-30 |
| K210264 | BD PowerPiCC Catheter | Bard Access Systems, Inc. | LJS | Class II | 2021-07-30 |
| K203796 | Firefly Needleless Connector | Puracath Medical, Inc. | FPA | Class II | 2021-07-30 |
| K210691 | Disposable Nitrile Medical Examination Glove | Jiangsu Cureguard Glove Co., Ltd. | LZA | Class I | 2021-07-30 |
| K203753 | Straumann Surgical Cassettes | Straumann USA, LLC | KCT | Class II | 2021-07-29 |
| K211131 | Disposable Nitrile Medical Examination Glove | Siyang Threeguard Medical Supplies Co., Ltd. | LZA | Class I | 2021-07-29 |
| K211229 | Vinyl compound examination gloves | Hebei Titans Hongsen Medical Technology Co., Ltd. | LYZ | Class I | 2021-07-29 |
| K211341 | Blue Nitrile Exam Gloves | Jiangxi Surefine Medical Co., Ltd. | LZA | Class I | 2021-07-29 |
| K203431 | Disposable Ear Thermometer Probe Cover | Huaian Zhongxin Packing Material Co., Ltd. | FLL | Class II | 2021-07-28 |
| K211455 | Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors | Shen Wei USA, Inc. | LZA | Class I | 2021-07-28 |
| K203359 | BD Flu+ Syringe | Becton, Dickinson and Company | FMF | Class II | 2021-07-28 |
| K211395 | NIO-I | Einstein Works, LLC | FMI | Class II | 2021-07-28 |
| K211262 | Disposable Vinyl Nitrile Synthetic Gloves Powder Free | Tangshan Hongyun Healthcare Products Co., Ltd. | LYZ | Class I | 2021-07-24 |
| K202060 | Disposable IV catheter | Shinva Ande Healthcare Apparatus Co., Ltd. | FOZ | Class II | 2021-07-23 |
| K202296 | Infrared Forehead Thermometer, Model BSX976 | Shenzhen Bsx Technology Electronics Co., Ltd. | FLL | Class II | 2021-07-23 |
| K211012 | Nitrile Patient Examination Gloves | Huayuan Medical Technology(Shangqiu) Co., Ltd. | LZA | Class I | 2021-07-23 |
| K211220 | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs | Guangdong Kingfa Sci. & Tech.Co., Ltd. | LZA | Class I | 2021-07-22 |
| K211968 | NIO+ Adult | Waismed, Ltd. | FMI | Class II | 2021-07-22 |
| K202603 | Temp Pal | Iweecare Co., Ltd. | FLL | Class II | 2021-07-22 |
| K210059 | Promisemed Insulin Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | FMI | Class II | 2021-07-21 |
| K210686 | Nitrile Patient Examination Glove | Yunnan Huazhiyuan Medical Technology Co., Ltd. | LZA | Class I | 2021-07-21 |
| K210684 | Disposable Nitrile Medical Examination Glove | Jiangsu Cureguard Glove Co., Ltd. | LZA | Class I | 2021-07-20 |
| K211239 | Vinyl Patient Examination Gloves | Jiangxi Shengda Medical Technology Co., Ltd. | LYZ | Class I | 2021-07-17 |
| K211177 | Powder Free Vinyl Patient Examination Gloves | Shijiazhuang Hongjun Plastic Manufacture Co., Ltd. | LYZ | Class I | 2021-07-17 |
| K210544 | Medtronic Extended infusion set | Unomedical A/S | FPA | Class II | 2021-07-16 |
| K210103 | SAFEWAY, LIFELONG PREMIUM, LIFELONG MATRIX | Lifelong Meditech Private Limited | FMF | Class II | 2021-07-16 |
| K200096 | Crosstex VH2O2 Chemical Indicators | Crosstex International, Inc. (A Cantel Medical Company) | JOJ | Class II | 2021-07-15 |
| K211547 | Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) | Edma Group, LLC | LZA | Class I | 2021-07-15 |
| K210723 | Nitrile Patient Examination Glove | Jiangxi Zhonghong Pulin Medical Products Co., Ltd. | LZA | Class I | 2021-07-12 |
| K210776 | Nitrile Examination Gloves | 5r Med Instruments (Chengdu) Co., Ltd. | LZA | Class I | 2021-07-12 |
| K210578 | Medical Nitrile Examination Gloves (Power free, Blue) | Jiangxi Hongda Medical Equipment Group , Ltd. | LZA | Class I | 2021-07-10 |
| K210821 | Medical PVC Examination Gloves | Jiangxi Hongda Medical Equipment Group , Ltd. | LYZ | Class I | 2021-07-09 |
| K202741 | Infrared Forehead Thermometer | Shenzhen Combei Technology Co., Ltd. | FLL | Class II | 2021-07-07 |
| K203198 | KARL STORZ Metal Sterilization Trays | Karl Storz Endoscopy America, Inc. | KCT | Class II | 2021-07-06 |
| K202570 | Insulin Syringe, Insulin Syringe with Safety Retractable | Jiangsu Micsafe Medical Technology Co., Ltd. | MEG | Class II | 2021-07-02 |
| K210326 | Bravo G4 Chamber Autoclave | Scican , Ltd. | FLE | Class II | 2021-07-01 |
| K211007 | EZ-TRAXTM Persona Knee Containment Device | K1 Medical, LLC | KCT | Class II | 2021-07-01 |
| K210587 | Violet Nitrile Powder Free Patient Examination Glove, Non Sterile | Onetexx Sdn Bhd | LZA | Class I | 2021-06-28 |
| K210775 | White Nitrile Powder Free Patient Examination Glove, Non Sterile | Onetexx Sdn Bhd | LZA | Class I | 2021-06-28 |
| K211293 | Safety Winged Blood Collection Sets | Promisemed Hangzhou Meditech Co., Ltd. | FMI | Class II | 2021-06-25 |
| K211252 | Nitrile Glove | Jiangsu Dihong Industry and Trade Co., Ltd. | LZA | Class I | 2021-06-25 |
| K201428 | Powder Free Black Nitrile Examination Glove | Vietglove Corporation | LZA | Class I | 2021-06-24 |
15,723 clearances in the General Hospital panel. Data: openFDA.