Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 28
- Latest Decision
- 2000-07-26
Clearances · page 68 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K001619 | MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE) | Multisafe Sdn. Bhd. | LZA | Class I | 2000-07-26 |
| K001497 | MULTISAFE-POWDERED NITRILE GLOVES, NON-STERILE (BLUE) | Multisafe Sdn. Bhd. | LZA | Class I | 2000-07-26 |
| K002033 | BD INSYTE AUTOGUARD -P AND BD INSYTE AUTOGUARD -P WINGED IV CATHETERS | Becton Dickinson Infusion Therapy Systems, Inc. | FOZ | Class II | 2000-07-26 |
| K001375 | ULTIMATE N-DEX POWER FREE NITRILE EXMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) | Best Manufacturing Company | LZA | Class I | 2000-07-25 |
| K001423 | KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY | Kawasumi Laboratories America, Inc. | FPA | Class II | 2000-07-21 |
| K001424 | KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD | Kawasumi Laboratories America, Inc. | FPA | Class II | 2000-07-21 |
| K001426 | KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTER | Kawasumi Laboratories America, Inc. | FPA | Class II | 2000-07-21 |
| K002126 | ABBOTT ACCLAIM ENCORE STANDARD TUBING PUMP | Abbott Laboratories | FRN | Class II | 2000-07-20 |
| K993996 | UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE | Univec, Inc. | MEG | Class II | 2000-07-17 |
| K001242 | ISOLETTE INFANT INCUBATOR, MODEL C2HS | Hill-Rom Air-Shields | FMZ | Class II | 2000-07-13 |
| K001861 | SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES | Shijiazhuang Hongxiang Plastics Products Co; , Ltd. | LYZ | Class I | 2000-07-11 |
| K001831 | NEEDLELESS TRANSFER DEVICE | Medimop Medical Projects, Ltd. | LHI | Class II | 2000-07-11 |
| K001837 | NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR BLUE | Shanghai Poseidon Plastic Products Co., Ltd. | LZA | Class I | 2000-07-11 |
| K001863 | SYNTHETIC POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES | Shijiazhuang Hongxiang Plastics Products Co; , Ltd. | LYZ | Class I | 2000-07-11 |
| K001432 | DISPOSABLE PVC SYNTHETIC EXAM GLOVES, POWDER FREE | Shanghai PM Plastics Ent. Co., Ltd. | LYZ | Class I | 2000-07-05 |
| K001337 | DANIELS SHARPSMART REUSABLE SHARPS CONTAINER | The Daniels Corp. | MMK | Class II | 2000-07-05 |
| K981089 | TISSOMAT AND SPRAY SET | Baxter Healthcare Corp | FMF | Class II | 2000-07-05 |
| K001715 | POWDERED PATIENT EXAMINATION GLOVES, LATEX | Fitco Dipped Products Pvt., Ltd. | LYY | Class I | 2000-07-05 |
| K001165 | POLYMER COATED POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | Medipure Corporation (M) Sdn. Bhd. | LYY | Class I | 2000-07-05 |
| K001834 | SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES | Shijiazhuang Hongxiang Plastics Products Co; , Ltd. | LYZ | Class I | 2000-06-30 |
| K000952 | HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATION GLOVES - BLUE COLOR | Pamitex Industries Sdn Bhd | LYY | Class I | 2000-06-30 |
| K001862 | SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES | Shijiazhuang Hongxiang Plastics Products Co; , Ltd. | LYZ | Class I | 2000-06-30 |
| K000860 | FUTURA SAFETY SYRINGE | Sheila W. Pickering | MEG | Class II | 2000-06-30 |
| K001674 | POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR | Pamitex Industries Sdn Bhd | LYY | Class I | 2000-06-30 |
| K001611 | DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE | Shanghai PT Plastics Enterprise Company, Ltd. | LYZ | Class I | 2000-06-30 |
| K000351 | HANWELLA LATEX PATIENT EXAM. GLOVES POWDER-FREE | Hanwella Rubber Products , Ltd. | LYY | Class I | 2000-06-23 |
| K001637 | DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, GREEN COLOR | Sheen More Ent. Co., Ltd. | LZA | Class I | 2000-06-23 |
| K001601 | DISPOSABLE PVC POWDERED SYNTHETIC EXAM GLOVES | Shanghai PT Plastics Enterprise Company, Ltd. | LYZ | Class I | 2000-06-23 |
| K001672 | POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES | Pamitex Industries Sdn Bhd | LYY | Class I | 2000-06-23 |
| K001649 | STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234 | Steritec Products, Inc. | JOJ | Class II | 2000-06-23 |
| K994384 | CLICKER | Bioject, Inc. | KZE | Class II | 2000-06-22 |
| K001240 | SERAGARD INJECTION PATCH | Platinum Services, Inc. | KGX | Class I | 2000-06-21 |
| K001718 | MILLENNIA ACUPUNCTURE NEEDLE | United Pacific Co., Ltd. | MQX | Class II | 2000-06-21 |
| K001629 | DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM | Disetronic Medical Systems AG | FRN | Class II | 2000-06-21 |
| K993125 | SAFETYTIP MULTI-SAMPLE NEEDLE, SAFETYTIP BLOOD COLLECTION SYSTEM | Safety Medical Supply Int,., Inc. | FMI | Class II | 2000-06-20 |
| K991999 | STERRAD 100S STERILIZER | Advanced Sterilization Products | MLR | Class II | 2000-06-15 |
| K992532 | VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING | Baxter Healthcare Corp | FOZ | Class II | 2000-06-13 |
| K001485 | HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE LATEX EXAMINATION GLOVES | Pwa Industries Sdn. Bhd. | LYY | Class I | 2000-06-13 |
| K001475 | HEALTH-PLUS, SANITEX, RELIANCE, POWDERED LATEX EXAM GLOVES CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PR | Pwa Industries Sdn. Bhd. | LYY | Class I | 2000-06-13 |
| K001529 | POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIM, CONTAINS 50 MICROGRAMS OR LESS OF TOTA | Perusahaan Getah Asas Sdn. Bhd. | LYY | Class I | 2000-06-12 |
| K993518 | MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE LL | Medefil, Inc. | FOZ | Class II | 2000-06-12 |
| K001549 | MULTIPLE PRIVATE LABELS, NITRILE EXAM GLOVES, POWDER-FREE (WHITE) | Shanghai Poseidon Plastic Products Co., Ltd. | LZA | Class I | 2000-06-12 |
| K001287 | EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML | Sorenson Medical, Inc. | KPE | Class II | 2000-06-09 |
| K001474 | TERUMO U-100 INSULIN SYRING | Terumo Medical Corp. | FMF | Class II | 2000-06-09 |
| K000377 | MASIF POWDER-FREE PATIENT EXAMINATION GLOVES | Masif Healthcare Products Sdn. Bhd. | LYY | Class I | 2000-06-09 |
| K001557 | LAXTEX POWDERED EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS) | Kossan Latex Industries(M)Sdn Bhd | LYY | Class I | 2000-06-09 |
| K000747 | UNIVEC TWO PIECE SYRINGE | Univec, Inc. | FMF | Class II | 2000-06-08 |
| K000813 | FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM | Allegiance Healthcare Coporation | LZA | Class I | 2000-06-08 |
| K000842 | CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM | Sims Deltec, Inc. | FRN | Class II | 2000-06-08 |
| K992404 | THE WAND | Spintech, Inc. | FMF | Class II | 2000-06-06 |
| K001017 | RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC | Retrax Safety Systems, Inc. | MEG | Class II | 2000-06-02 |
| K993775 | STERRAD BI TEST PACK | Advanced Sterilization Products | FRC | Class II | 2000-06-01 |
| K000456 | HARVEST TECHNOLOGIES DUAL LIQUID APPLICATOR, MODEL SK/S: HARVEST DUAL LIQUID APPLICATOR LK/2 | Harvest Technologies, LLC | FMF | Class II | 2000-06-01 |
| K990331 | SURGEN VALVE | Tiva Medical | FPA | Class II | 2000-05-31 |
| K983068 | RELIANCE FAMILY OF WASHER-DISINFECTORS | STERIS Corporation | LDS | Class II | 2000-05-31 |
| K994274 | QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB) | Quest Medical, Inc. | FRN | Class II | 2000-05-31 |
| K000719 | NEOCARE 20 MICRON BLOOD FILTER | Whatman, Inc. | CAK | Class II | 2000-05-30 |
| K001065 | DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR | Sheen More Ent. Co., Ltd. | LZA | Class I | 2000-05-23 |
| K001155 | DISPOSABLE POWDERED NITRILE EXAM GLOVE, WHITE COLOR | Sheen More Ent. Co., Ltd. | LZA | Class I | 2000-05-23 |
| K001128 | NITRILE EXAM GLOVES, POWDER-FREE, COLOR BLUE | Shanghai Poseidon Plastic Products Co., Ltd. | LZA | Class I | 2000-05-23 |
| K994426 | GLOVETEX, LATEX EXAMINATION GLOVES, POWDERED NON-STERILE.(PROTEIN CONTENT LABELING) | Pt. Wrp Buana Multicorpora | LYY | Class I | 2000-05-23 |
| K994098 | VINYL PATIENT EXAMINATION GLOVES-POWDER FREE | Evergreen Medical Produts (Jingxing) Co., Ltd. | LYZ | Class I | 2000-05-23 |
| K001042 | COMFORT LATEX POWDERED PATIENT EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATE | Comfort Rubber Gloves Industries Sdn. Bhd. | LYY | Class I | 2000-05-23 |
| K001190 | POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PE | Kossan Latex Industries(M)Sdn Bhd | LYY | Class I | 2000-05-23 |
| K001327 | POWDERED LATEX EXAM GLOVES, PROTEIN LABELING (150 MICROGRAM OR LESS) | Premier Pathway Sdn. Bhd. | LYY | Class I | 2000-05-23 |
| K000999 | MULTISAFE POWDER-FREE PATIENT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | Multisafe Sdn. Bhd. | LYY | Class I | 2000-05-22 |
| K001098 | PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01 | Pro. Duct Health, Inc. | FMI | Class II | 2000-05-18 |
| K001381 | CIDEX OPA SOLUTION | Advanced Sterilization Products | MED | Class II | 2000-05-17 |
| K001280 | COMFIT POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE, NON STERILE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LES | Wrp Asia Pacific Sdn. Bhd. | LYY | Class I | 2000-05-15 |
| K993760 | POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200 MICROGRAMS OR LESS | Hartalega Sdn Bhd | LYY | Class I | 2000-05-15 |
| K001232 | NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM 50 MICROGRAMS OR LESS | Fitco Dipped Products Pvt., Ltd. | LYY | Class I | 2000-05-15 |
| K001444 | STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103 | Steritec Products, Inc. | JOJ | Class II | 2000-05-15 |
| K001368 | PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER | Carmel Pharma Ab. | LHI | Class II | 2000-05-12 |
| K000472 | POSI-LINK | Icu Medical, Inc. | FPA | Class II | 2000-05-10 |
| K000263 | GO MEDICAL BALLOON INFUSION SYSTEM | Go Medical Industries Pty. , Ltd. | MEB | Class II | 2000-05-09 |
| K001141 | POWDER FREE STERILE LATEX EXAMINATION GLOVES | Allegiance Healthcare Corp. | LYY | Class I | 2000-05-09 |
| K000328 | MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP | Medex, Inc. | FRN | Class II | 2000-05-09 |
| K000420 | SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003 | Retinalabs.Com | MRH | Class II | 2000-05-08 |
| K001293 | MODIFICATION TO MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PRE-ATTACHED NEEDLE | Medimop Medical Projects, Ltd. | LHI | Class II | 2000-05-05 |
| K000816 | SHARP BRAND ACUPUNCTURE NEEDLES | Tcm Supply Corp. | MQX | Class II | 2000-05-04 |
| K000438 | MULTI LUMEN SUCTION SYRINGE SPRAY DISPENSER | Biosurgical Corp. | FMF | Class II | 2000-05-03 |
| K991422 | POWDER-FREE NITRILE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) | Shen Wei (Usa), Inc. | LZA | Class I | 2000-05-03 |
| K000745 | SENSI GRIP LATEX EXAMINATION GLOVE, POWDERED CONTAINS 200 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM | Tillotson Healthcare Corp. | LYY | Class I | 2000-05-03 |
| K000665 | TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER | Tfx Medical, Inc. | FOZ | Class II | 2000-05-02 |
| K000667 | POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER LABEL CLAIM | Protection Gloves Sdn. Bhd. | LYY | Class I | 2000-04-28 |
| K000891 | STERILE LATEX POWDERED PATIENT EXAMINATION GLOVES | Fitco Dipped Products Pvt., Ltd. | LYY | Class I | 2000-04-28 |
| K001279 | GT990402 DIGITAL THERMOMETER | Global Treasure , Ltd. | FLL | Class II | 2000-04-28 |
| K001216 | POWDER-FREE LATEX EXAMINATION GLOVE STERILE WITH OPTIONAL PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) | Fitco Dipped Products Pvt., Ltd. | LYY | Class I | 2000-04-28 |
| K000689 | UNIGLOVE NITRILE POWDER-FREE EXAMINATION GLOVES | N.S. Uni-Gloves Sdn. Bhd. | LZA | Class I | 2000-04-28 |
| K000299 | DERMAPIK II SKIN TEST SYSTEM, DERMAPIK II (SINGLE TEST DEVICE), POLYPIK II (MULTIPLE SKIN TEST DEVICE), DERMAPIK TRAY, D | Biomedex, Inc. | SCL | Class II | 2000-04-28 |
| K000668 | POWDER-FREE NON-VHLORINATED POLYMER COATED LATEX EXAMINATION GLOVES CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRA | Protection Gloves Sdn. Bhd. | LYY | Class I | 2000-04-28 |
| K001094 | SAFE TOUCH NATURAL RUBBER POWDERED LATEX EXAMINATION GLOVES | Jb Star Sdn Bhd | LYY | Class I | 2000-04-28 |
| K000942 | CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090 | Sims Deltec, Inc. | FPA | Class II | 2000-04-27 |
| K001019 | TI500 GLOBE-TROTTER TRANSPORT SYSTEM | Hill-Rom Air-Shields | FPL | Class II | 2000-04-27 |
| K994023 | HAEMACURE HEMAMYST SURGICAL APPLICATOR SYSTEM H-AS01 | Haemacure Corp. | FMF | Class II | 2000-04-25 |
| K000985 | MATANG POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS | Matang Mfg. Sdn. Bhd. | LYY | Class I | 2000-04-24 |
| K000867 | POWDER FREE LATEX EXAMINATION GLOVES, PEPPERMINT SCENTED (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN GR | Sgmp Co., Ltd. | LYY | Class I | 2000-04-21 |
| K993871 | BIOSHIELD HEAVY DUTY AND SUPER DUTY EXPRESS STERILIZATION WRAP | Allegiance Healthcare Corp. | FRG | Class II | 2000-04-21 |
| K000650 | BETEL POWDER FREE LATEX EXAM GLOVES | Betel Care Sdn. Bhd. | LYY | Class I | 2000-04-20 |
| K992732 | STERILE WATER & STERILE 0.9% SODIUM CHLORIDE | Dumex Medical Surgical Products, Ltd. | FOZ | Class II | 2000-04-20 |
15,723 clearances in the General Hospital panel. Data: openFDA.