Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 23
- Latest Decision
- 2021-12-11
Clearances · page 13 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K212899 | Disposable Vinyl/Nitrile Blend Medical Examination Gloves | Bytech(Dongtai) Co., Ltd. | LYZ | Class I | 2021-12-11 |
| K201600 | Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27, KFT-28 | Kangfu Medical Equipment Factory | FLL | Class II | 2021-12-10 |
| K212922 | Nitrile Examination Gloves | Hsk Medical Apparatus Foshan China Co., Ltd. | LZA | Class I | 2021-12-10 |
| K212349 | Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination Gloves | Medi Legion Sdn.Bhd | LZA | Class I | 2021-12-10 |
| K212850 | ComfortPro Blue Nitrile Examination Gloves Powder Free | Thai Rubber Industry Company Limited | LZA | Class I | 2021-12-10 |
| K213371 | Disposable Medical Nitrile Examination Gloves (Model:XYS-001) | Anhui Xinyisheng Medical Technology Co.,Ltd | LZA | Class I | 2021-12-09 |
| K213156 | BD Nano 2nd Gen Pen Needle | Becton, Dickinson and Company | FMI | Class II | 2021-12-08 |
| K212639 | Disposable Medical Nitrile Examination Gloves (Non sterile) | Jiangsu Nanfang Medical Co., Ltd. | LZC | Class I | 2021-12-08 |
| K211629 | Infrared forehead thermometer LD-FT-100B | Honsun (Nantong) Co., Ltd. | FLL | Class II | 2021-12-08 |
| K212438 | Comfortpro | Thai Rubber Industry Company Limited | LYY | Class I | 2021-12-07 |
| K212827 | Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | LZC | Class I | 2021-12-06 |
| K212535 | Nitrile Powder Free Blue Examination Gloves, Non-Sterile | Mah Sing Healthcare Sdn. Bhd. | LZA | Class I | 2021-12-04 |
| K212802 | powder free nitrile examination glove - white, non-sterile | Hong Seng Gloves Sdn Bhd | LZA | Class I | 2021-12-02 |
| K212578 | Nitrile disposable examination gloves | Xingyu Medical Tech Co., Ltd. | LZA | Class I | 2021-12-02 |
| K212804 | Powder free nitrile examination glove- blue, non-sterile | Hong Seng Gloves Sdn Bhd | LZA | Class I | 2021-12-01 |
| K212789 | Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) | 5r Med Instruments (Chengdu) Co., Ltd. | LZA | Class I | 2021-12-01 |
| K210836 | InstruSafe Instrument Protection System | Summitt Medical, LLC | KCT | Class II | 2021-11-30 |
| K212722 | Nitrile Examination Gloves | Wuhan Huirui Technology Co., Ltd. | LZA | Class I | 2021-11-26 |
| K212488 | Synthetic Nitrile Examination Gloves | Shandong Hongxin Chemicals Co., Ltd. | LYZ | Class I | 2021-11-26 |
| K211139 | CUBE Air Purifier | Samsung Electronics Co., Ltd. | FRA | Class II | 2021-11-26 |
| K211744 | Non-Contact Infrared Thermometer, model HL710H | Health & Life Co., Ltd. | FLL | Class II | 2021-11-24 |
| K211649 | PCEA Syringe Set | Baxter Healthcare Corporation | PWH | Class II | 2021-11-23 |
| K210990 | Non-sterile Powder Free Nitrile Examination Gloves | Rubberex Alliance Sdn Bhd | LZA | Class I | 2021-11-22 |
| K203074 | Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile) | Pt. Universal Gloves | LYY | Class I | 2021-11-19 |
| K212661 | Disposable Nitrile Examination Glove | Inner Mongolia Cureguard Medical Technology Co., Ltd. | LZA | Class I | 2021-11-19 |
| K211063 | HALYARD Flexaprene Green Powder-Free Exam Glove | O&M Halyard, Inc. | LZA | Class I | 2021-11-19 |
| K212015 | BD Nano 2nd Gen Pen Needle | Becton, Dickinson and Company | FMI | Class II | 2021-11-19 |
| K212600 | Disposable Medical Nitrile Examination Gloves (Non-sterile) | Suqian Linglian Medical Technology Co., Ltd. | LZA | Class I | 2021-11-18 |
| K211890 | Promisemed Sharps container | Promisemed Hangzhou Meditech Co., Ltd. | MMK | Class II | 2021-11-17 |
| K212029 | Disposable Medical Nitrile Examination Gloves (non-sterile) | Taizhou Kangjian Medical Equipments Co., Ltd. | LZA | Class I | 2021-11-16 |
| K211329 | Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle | Jiangsu Kangbao Medical Equipment Co., Ltd. | MEG | Class II | 2021-11-15 |
| K202319 | Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) | Tianjin Huahong Technology Co., Ltd. | FMI | Class II | 2021-11-12 |
| K212497 | Nitrile Examination Glove (Powder free, Blue) | Jiangsu Jinlian Medical Technology Co., Ltd. | LZA | Class I | 2021-11-11 |
| K212532 | Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs) | Crdlight Optoelectronic Technology Co., Ltd. | LZA | Class I | 2021-11-11 |
| K210779 | Powder Free Nitrile Patient Examination Gloves, Blue Color | Shandong Shangwei Medical Products Co., Ltd. | LZA | Class I | 2021-11-10 |
| K213089 | Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector | Ivenix, Inc. | FPA | Class II | 2021-11-10 |
| K211206 | FreedomEdge(R) Syringe Infusion System | Repro-Medical System, Inc., Dba Koru Medical Systems | FRN | Class II | 2021-11-09 |
| K212068 | Biotech Dental Kits | Biotech Dental, Sas | KCT | Class II | 2021-11-08 |
| K212506 | Medical Examination Gloves (Tested for Use with Chemotherapy) | Guangdong Gymda Medical Technology Co.,Ltd | LZA | Class I | 2021-11-07 |
| K212551 | Nitrile Examination Gloves | Anhui Fine Glove Medical Technology Co., Ltd. | LZA | Class I | 2021-11-05 |
| K210253 | Best Glove-Latex Powder Free Examination Glove | Bestsafe Glove Co., Ltd. | LYY | Class I | 2021-11-05 |
| K212485 | Disposable Nitrile Examination gloves | Fujian Yuanxin Safety Protection Technology Co., Ltd. | LZA | Class I | 2021-11-05 |
| K212467 | Disposable Nitrile Examination Glove | Inner Mongolia Boming Medical Supplies Co., Ltd. | LZA | Class I | 2021-11-04 |
| K211103 | Powder Free Vinyl Examination Gloves | Shanghai Shengda Medical Applications Co., Ltd. | LYZ | Class I | 2021-11-04 |
| K212404 | S.I.N. Instrument Kits | S.I.N. - Sistema DE Implante Nacional S.A. | KCT | Class II | 2021-11-03 |
| K202732 | SOL-CARE IV Bag Safety Connector | Sol-Millennium Medical Group | LHI | Class II | 2021-11-03 |
| K210777 | Powder Free Nitrile Patient Examination Gloves, Blue Color | Shandong Jieshi Medical Products Co., Ltd. | LZA | Class I | 2021-11-02 |
| K212338 | SterileRight sterilization pouch and roll | Sterileright Packaging Mfg., Inc. | FRG | Class II | 2021-11-01 |
| K211586 | Nitrile Examination Gloves (Blue, Violet) | Lyncmed Medical Technology (Beijing) Co., Ltd. | LZA | Class I | 2021-11-01 |
| K210588 | Black Nitrile Powder Free Patient Examination Glove, Non Sterile | Onetexx Sdn Bhd | LZA | Class I | 2021-10-31 |
| K212308 | SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free | Srirungruang Global Co., Ltd. | LZA | Class I | 2021-10-29 |
| K210279 | Enbio S | Enbio Group AG | FLE | Class II | 2021-10-29 |
| K201032 | Phoenix Digital Thermometer | Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd. | FLL | Class II | 2021-10-29 |
| K211581 | Disposable Nitrile Examination Gloves (Powder free, Blue) | Leping Shengde Medical Technology Company Limited | LZA | Class I | 2021-10-28 |
| K212290 | Examination gloves -Type C (Nitrile gloves) | Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. | LZA | Class I | 2021-10-28 |
| K212424 | AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers | STERIS Corporation | FLE | Class II | 2021-10-28 |
| K211604 | Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs | Shanxi Hongjin Plastic Technology Co., Ltd. | LZA | Class I | 2021-10-27 |
| K212363 | Disposable Medical Nitrile Examination Gloves | Lanhuo Medical Technology (Jiangsu) Co.,Ltd | LZA | Class I | 2021-10-26 |
| K213085 | Introcan Safety 3 Closed IV Catheter | B.Braun Medical, Inc. | FOZ | Class II | 2021-10-25 |
| K212401 | Disposable Nitrile Examination Glove | Inner Mongolia Cureguard Medical Technology Co., Ltd. | LZA | Class I | 2021-10-25 |
| K210249 | Best Glove-Nitrile Powder Free Examination Glove | Bestsafe Glove Co., Ltd. | LZA | Class I | 2021-10-25 |
| K211698 | Vinyl Examination Gloves(Yellow) | Liuping Trading Co., Ltd. | LYZ | Class I | 2021-10-24 |
| K212396 | UroLift System Rigid Retrieval Kit Sterilization Tray | Neotract, Inc. | KCT | Class II | 2021-10-22 |
| K212193 | Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | Plasmapp Co,., Ltd. | FRC | Class II | 2021-10-22 |
| K212198 | Tyvek(R) Roll with CI for STERLINKTM Sterilizer | Plasmapp Co,., Ltd. | FRG | Class II | 2021-10-22 |
| K212200 | STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette | Plasmapp Co,., Ltd. | MLR | Class II | 2021-10-22 |
| K212311 | Medical Examination Gloves | Guangzhou Junda Gloves Co., Ltd. | LZA | Class I | 2021-10-21 |
| K210706 | Nitrile Examination Gloves | Niujian Technology Co., Ltd. | LZA | Class I | 2021-10-19 |
| K211555 | Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | MEG | Class II | 2021-10-18 |
| K211121 | Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit | Intera Oncology, Inc. | PTI | Class II | 2021-10-14 |
| K211753 | Sterile Syringe With Safety Needle | Jiangxi Hongda Medical Equipment Group , Ltd. | MEG | Class II | 2021-10-14 |
| K211214 | Sterile Hypodermic Needles for Single Use | Azur Medical Company, Inc. | FMI | Class II | 2021-10-14 |
| K211914 | Nitrile Patient Examination Gloves | Yingxiang Glove Products Co., Ltd. | LZA | Class I | 2021-10-14 |
| K211374 | Proclean - Nitrile Powder Free Examination Gloves | Dr.Boo Company Limited | LZA | Class I | 2021-10-13 |
| K212014 | Medical Nitrile Examination Gloves | Jiangxi Ronglai Medical Technology Co., Ltd. | LZA | Class I | 2021-10-13 |
| K212544 | MiniLoad Syringe | Ocuject, LLC | FMF | Class II | 2021-10-13 |
| K211927 | Nitrile examination gloves | Fitone Latex Products Co., Ltd. Guangdong | LZA | Class I | 2021-10-12 |
| K212174 | STERRAD 100NX Sterilizer with ALLClear Technology | Advanced Sterilization Products, Inc. | MLR | Class II | 2021-10-09 |
| K211680 | Streamline Surgical System | New World Medical, Inc. | MRH | Class II | 2021-10-08 |
| K203497 | Infrared Thermometer (Model K9) | Kangzhan Communication Electronics Co., Ltd. | FLL | Class II | 2021-10-08 |
| K212078 | Medical Examination Gloves | Guangdong Gymda Medical Technology Co.,Ltd | LZA | Class I | 2021-10-08 |
| K211211 | Sterile syringes for single use with/without needle | Azur Medical Company, Inc. | FMF | Class II | 2021-10-07 |
| K211719 | ZinRom Nitrile examination gloves | Changzhou Xingrong Medical Technology Co., Ltd. | LZA | Class I | 2021-10-06 |
| K212036 | Nitrile Powder Free Examination Gloves,Tested For Use With Chemotherapy Drugs | Jiangsu Yanfang Medical Technology Co., Ltd. | LZA | Class I | 2021-10-05 |
| K211728 | Sterile hypodermic syringes for single use | Jiangsu Kangyou Medical Instrument Co., Ltd. | FMF | Class II | 2021-10-05 |
| K212805 | SteriCap Mini Needle and Standard Needles | Ocuject, LLC | FMI | Class II | 2021-09-30 |
| K203609 | Intravascular Administration Sets | Baxter Healthcare Corporation | FPA | Class II | 2021-09-30 |
| K212226 | DR Safety Syringe, Sterile Hypodermic needle for Single use | Zhuhai DR Medical Instruments Co., Ltd. | MEG | Class II | 2021-09-29 |
| K211781 | Disposable Nitrile Gloves | Jiangsu Jinke Protective Equipment Co., Ltd. | LZA | Class I | 2021-09-29 |
| K202481 | ThermArt (Model IR-EFT) | Comper Chuangxiang (Beijing) Technology Co., Ltd. | FLL | Class II | 2021-09-28 |
| K211236 | Disposable Vinyl Examination Gloves | Tangshan Hongyun Healthcare Products Co., Ltd. | LYZ | Class I | 2021-09-27 |
| K203674 | B Dispensing Line | Aea Srl | LHI | Class II | 2021-09-27 |
| K203731 | DT100 Digital Thermometer | Smart Technology Co., Ltd. | FLL | Class II | 2021-09-26 |
| K202618 | IV Administration Sets | B.Braun Medical, Inc. | FPA | Class II | 2021-09-24 |
| K210232 | Sterile Hypodermic Needles for Single Use | Zhejiang Kangkang Medical-Devices Co., Ltd. | FMI | Class II | 2021-09-23 |
| K212002 | Synthetic Vinyl Examination Gloves | Yunnan Huazhiyuan Medical Technology Co., Ltd. | LYZ | Class I | 2021-09-23 |
| K210707 | OnGuard2 Chemfort Closed Administration (CADM) | Simplivia Healthcare , Ltd. | ONB | Class II | 2021-09-23 |
| K203662 | Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11 | Yibin Junxin Electronics Technology Co., Ltd. | FLL | Class II | 2021-09-23 |
| K211073 | Disposable Nitrile Examination Gloves | Foshan Kangkang Biotechnology Co., Ltd. | LZA | Class I | 2021-09-21 |
| K211931 | Medline Digital Thermometer Non-Lubricated Probe Sheath | Medline Industries, Inc. | FLL | Class II | 2021-09-20 |
15,723 clearances in the General Hospital panel. Data: openFDA.