Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 37
- Latest Decision
- 2017-09-20
Clearances · page 23 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K171541 | Powder Free Nitrile Examination Gloves (Orange) | Comfort Rubber Gloves Industries Sdn. Bhd. | LZA | Class I | 2017-09-20 |
| K170002 | Medline Blood Collection Set | Medline Industries, Inc. | FPA | Class II | 2017-09-19 |
| K163518 | Digital Thermometer | Joytech Healthcare Co. , Ltd. | FLL | Class II | 2017-09-19 |
| K170640 | Endoscope Sterilization Tray | Intuitive Surgical, Inc. | KCT | Class II | 2017-09-17 |
| K172506 | BD Cathena Safety IV Catheter | Becton, Dickinson and Company | FOZ | Class II | 2017-09-17 |
| K171378 | Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs | Semperit Investments Asia Pte , Ltd. | LZA | Class I | 2017-09-14 |
| K171144 | Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel | Medbio, LLC | FMI | Class II | 2017-09-12 |
| K171317 | Clear Vinyl Powder-free Patient Examination Gloves | Shandong Zhi Hong Medical Products, Co. , Ltd. | LYZ | Class I | 2017-09-11 |
| K171805 | Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml | Conceptomed AS | FMF | Class II | 2017-09-08 |
| K171667 | Powder Free Nitrile Examination Glove | Professional Latex Sdn Bhd | LZA | Class I | 2017-09-08 |
| K171117 | Carefusion NeutraClear Needle-free connector (EL-NC1000) | Cair Lgl | FPA | Class II | 2017-09-01 |
| K163337 | Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer | Midmark Corporation | FLE | Class II | 2017-08-31 |
| K162613 | Integrated Catch-up Freedom Syringe Driver Infusion System | Repro-Med Systems, Inc. Dba Rms Medical Products | FRN | Class II | 2017-08-31 |
| K162165 | ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump | Summit Medical Products, Inc. | MEA | Class II | 2017-08-29 |
| K172207 | Standard Supreme Sterilization Wrapper | Standard Textile Co., Inc. | FRG | Class II | 2017-08-25 |
| K170136 | Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs | Shandong Feiyang Professional Gloves Co., Ltd. | LZA | Class I | 2017-08-25 |
| K171346 | Sapphire Sets | Icu Medical | MRZ | Class II | 2017-08-25 |
| K171104 | Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue) | Yty Industry (Manjung) Sdn Bhd | LZA | Class I | 2017-08-25 |
| K170982 | CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM) | Smiths Medical Ads, Inc. | MEA | Class II | 2017-08-24 |
| K171587 | VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator | STERIS Corporation | FRC | Class II | 2017-08-22 |
| K171504 | VERIFY Assert VH2O2 Self-Contained Biological Indicator | STERIS Corporation | FRC | Class II | 2017-08-22 |
| K170003 | Zip 4 Skin Closure Device | Zipline Medical, Inc. | PYO | Class I | 2017-08-18 |
| K172204 | BD Intima II PLUS Closed IV Catheter System | Becton, Dickinson and Company | FOZ | Class II | 2017-08-17 |
| K162917 | Allerhope Allergy Skin Tester | Procare Industrial Co., Limited | SCL | Class II | 2017-08-17 |
| K171118 | Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s) | Cair Lgl | FPA | Class II | 2017-08-15 |
| K170321 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248 | 3M Company | JOJ | Class II | 2017-08-14 |
| K171735 | PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set | C.R. Bard, Inc. | PTI | Class II | 2017-08-08 |
| K170939 | Supplemental Instrument Trays | Nuvasive Specialized Orthopedics, Incorporated | KCT | Class II | 2017-08-08 |
| K171362 | Merit Syringe | Merit Medical Systems, Inc. | FMF | Class II | 2017-08-07 |
| K172039 | CATHTONG II PICC Catheter | L&Z Us, Inc. | LJS | Class II | 2017-08-03 |
| K170651 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle | Yangzhou Medline Industry, Co., Ltd. | MEG | Class II | 2017-08-02 |
| K171132 | Carefusion NeutraClear Needle-free connector | Cair Lgl | FPA | Class II | 2017-07-31 |
| K171615 | Xingyu Nitrile Powder Free Patient Examination Gloves, White color | Shandong Xingyu Gloves Co., Ltd. | LZA | Class I | 2017-07-31 |
| K163598 | Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator | Advanced Sterilization Products | KCT | Class II | 2017-07-31 |
| K162951 | TUBETECH IV Administration Set | Douglas Medical Products, Inc. | FPA | Class II | 2017-07-28 |
| K171905 | VISCO 360 Viscosurgical System | Sight Sciences, Inc. | MRH | Class II | 2017-07-27 |
| K170563 | 3M Comply Hydrogen Peroxide Indicator Tape | 3M Company | JOJ | Class II | 2017-07-27 |
| K163597 | VacLok AT Vacuum Syringe | Merit Medical Systems, Inc. | PUR | Class II | 2017-07-27 |
| K163400 | Orbit Inserter | Ypsomed AG | KZH | Class II | 2017-07-26 |
| K170769 | wireless thermometer | Ech (Changzhou) Medical Instrument Co., Ltd. | FLL | Class II | 2017-07-26 |
| K162312 | Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color | Shen Wei USA, Inc. | LZA | Class I | 2017-07-25 |
| K170305 | Spinal Manometer NRFit; Spinal Manometer LUER | PAJUNK GmbH Medizintechnologie | FMJ | Class II | 2017-07-25 |
| K170770 | CT Midline | Medical Components, Inc. (dba MedComp) | PND | Class II | 2017-07-25 |
| K162858 | NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST | Careplus (M) Sdn Bhd | LZC | Class I | 2017-07-24 |
| K171003 | 3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader | 3M Company | FRC | Class II | 2017-07-21 |
| K171616 | Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color | Shandong Xingyu Gloves Co., Ltd. | LZA | Class I | 2017-07-20 |
| K162219 | CADD® Infusion Disposables Portfolio with NRFit connectors | Smiths Medical Asd, Inc. | PWH | Class II | 2017-07-20 |
| K170219 | Microlife Digital Infrared Ear Thermometer | Microlife Intellectual Property GmbH | FLL | Class II | 2017-07-20 |
| K171093 | STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE | Sanrea Healthcare Products Pvt, Ltd. | LZA | Class I | 2017-07-19 |
| K170675 | Graftgun Universal Graft Delivery System | SurGenTec, LLC | FMF | Class II | 2017-07-19 |
| K171957 | MaxZero Extension Sets with Needless Connector | Carefusion 303, Inc. | FPA | Class II | 2017-07-19 |
| K171333 | 20G x 5/8 Pro-Lock CT Safety Infusion Set | Medcomp (Dba Medical Components, Inc.) | PTI | Class II | 2017-07-18 |
| K162510 | Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue | Ug Global Resources Sdn. Bhd. | LZA | Class I | 2017-07-18 |
| K170686 | Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs | Brightway Holdings Sdn. Bhd. | LZA | Class I | 2017-07-14 |
| K162815 | SterilContainer S System | Aesculap, Inc. | KCT | Class II | 2017-07-13 |
| K170768 | Mini Needle | Ocuject, LLC | FMI | Class II | 2017-07-10 |
| K170397 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs | Kossan International Sdn Bhd | LZA | Class I | 2017-07-10 |
| K163035 | DilaCheck Nitrile Powder Free Examination Glove, (Sterile) | Elm Tree Medical, Inc. | LZA | Class I | 2017-07-07 |
| K171339 | EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs | Eco Medi Glove Sdn. Bhd. | LZA | Class I | 2017-07-07 |
| K170706 | Equashield Closed System drug Transfer Device (CSTD) | Equashield Medical , Ltd. | ONB | Class II | 2017-07-03 |
| K170794 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White) | Hartalega NGC Sdn. Bhd. | LZA | Class I | 2017-06-30 |
| K171533 | Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap | Ahlstrom Nonwovens, LLC | FRG | Class II | 2017-06-29 |
| K170735 | Powder-Free Clear Vinyl Patient Examination Gloves | Zibo Yue Fan Medical Products Co, Ltd. | LYZ | Class I | 2017-06-27 |
| K162993 | Gemini Sterilization Wrap | Medline Industries, Inc. | FRG | Class II | 2017-06-23 |
| K170094 | POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED | Vietglove Corporation | LYY | Class I | 2017-06-23 |
| K163437 | hypodermic Pinpoint GT Needle | C.R. Bard, Inc. | PVZ | Class II | 2017-06-23 |
| K162821 | Babyleo TN500 | Draegerwerk AG & CO Kgaa | FMZ | Class II | 2017-06-23 |
| K161808 | Solution Set with 1.2 Micron Air Eliminating Filter | Baxter Healthcare Corporation | FPA | Class II | 2017-06-21 |
| K170039 | STERRAD VELOCITY Biological Indictator and Reader | Advanced Sterilization Products (Asp) | FRC | Class II | 2017-06-20 |
| K162826 | Encore Neutral | Rymed Technologies, LLC | FPA | Class II | 2017-06-15 |
| K170848 | Alzair Allergy Blocker | Nasaleze International, Ltd. | NUP | Class II | 2017-06-14 |
| K161883 | CompuFlo Epidural Computer Controlled Anesthesia System | Milestone Scientific, Inc. | FMF | Class II | 2017-06-09 |
| K163357 | OneTouch Via On-Demand Insulin Delivery System | Lifescan Europe, A Division of Cilag GmbH | OPP | Class II | 2017-06-07 |
| K163603 | Digital Thermometer | Guangzhou Jinxinbao Electronic Co., Ltd. | FLL | Class II | 2017-06-06 |
| K171101 | Closed Male Luer | Yukon Medical | FPA | Class II | 2017-06-02 |
| K170158 | PowerGlide ST Midline Catheter | C.R. Bard, Inc. | PND | Class II | 2017-06-01 |
| K162601 | Infusion Set for Single Use | Shinva Ande Healthcare Apparatus Co., Ltd. | FPA | Class II | 2017-05-31 |
| K170486 | CATHTONG II PICC Catheter | L&Z Us, Inc. | LJS | Class II | 2017-05-25 |
| K170290 | Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr | Shen Wei USA, Inc. | LZA | Class I | 2017-05-24 |
| K170779 | Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein | Terang Nusa Sdn Bhd | LYY | Class I | 2017-05-24 |
| K161833 | LATEX EXAMINATION GLOVE POWDER FREE | Careglove Global Sdn. Bhd. | LYY | Class I | 2017-05-23 |
| K163553 | Powder Free Nitrile Patient Examination Gloves, Blue | Hebei Titans Medical Supply Technology Group., Ltd. | LZA | Class I | 2017-05-22 |
| K170575 | Disposable Powder Free Vinyl Exam Glove, Clear/Yellow | Ever Global (Vietnam) Enterprise Corp | LYZ | Class I | 2017-05-16 |
| K170680 | TEVADAPTOR Closed Drug Reconstitution and Transfer System | Teva Medical Ltd., Migada Plant | ONB | Class II | 2017-05-16 |
| K170228 | Belimed Steam Sterilizer MST-H TOP 5000 | Belimed AG | FLE | Class II | 2017-05-12 |
| K162566 | AIK Sterile Acupuncture Needles for Single Use | Changchun Aik Medical Devices Co., Ltd. | MQX | Class II | 2017-05-11 |
| K161961 | UniTex Non-Sterile, Powder-Free, Latex Examination Glove | Ug Global Resources Sdn. Bhd. | LYY | Class I | 2017-05-11 |
| K161950 | Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | FMI | Class II | 2017-05-11 |
| K170393 | Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue) | Zibo Chengxun Automatic Device Co., Ltd. | LZA | Class I | 2017-05-09 |
| K151562 | Resultz Lice & Egg Removal Kit | Piedmont Pharmaceuticals, LLC | LJL | Class I | 2017-05-08 |
| K170070 | VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles | STERIS Corporation | FRC | Class II | 2017-04-28 |
| K162945 | VERIFY ASSERT STEAM Process Challenge Device | STERIS Corporation | OWP | Class II | 2017-04-28 |
| K163358 | Introcan Safety 3 Closed IV Catheter | B.Braun Melsungen AG | FOZ | Class II | 2017-04-28 |
| K162258 | Self Sealing Sterilization Pouches | Tianchang Jiarui Packaging Material Co., Ltd. | FRG | Class II | 2017-04-28 |
| K160730 | Instrument kits | Anthogyr | KCT | Class II | 2017-04-27 |
| K162271 | Pro-Lock CT Safety Infusion Set | Medcomp (Medical Components, Inc.) | PTI | Class II | 2017-04-26 |
| K163507 | Triton Sponge System | Gauss Surgical, Inc., | PBZ | Class II | 2017-04-25 |
| K162441 | PowerPICC Provena Catheters with SOLO Valve Technology | C.R. Bard, Inc. | LJS | Class II | 2017-04-24 |
| K162294 | BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS | Brightway Holdings Sdn. Bhd. | LZA | Class I | 2017-04-21 |
| K162063 | Steri-Cassette and Steri-Cage Sterilization Packaging System | Sybron Dental Specialties | KCT | Class II | 2017-04-21 |
15,723 clearances in the General Hospital panel. Data: openFDA.