Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 25
- Latest Decision
- 2000-11-07
Clearances · page 67 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K003133 | MULTIPLE-VINYL EXAM GLOVE, POWDERED | Excellence Ent. Co., Ltd. | LYZ | Class I | 2000-11-07 |
| K003193 | DUPLOGRIP | Baxter Healthcare Corp | FMF | Class II | 2000-11-07 |
| K003087 | MODIFICATION TO SPORICIDIN STERILIZING AND DISINFECTING SOLUTION | Sporicidin Intl. | MED | Class II | 2000-11-07 |
| K003233 | RS NITRILSTST MEDICAL EXAMINATION GLOVES, POWDERED (NON STERILE) BLUE | Riverstone Resources Sdn Bhd | LZA | Class I | 2000-11-03 |
| K003006 | TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION | Arrow Intl., Inc. | LJT | Class II | 2000-10-27 |
| K003232 | RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE) | Riverstone Resources Sdn Bhd | LZA | Class I | 2000-10-26 |
| K994321 | STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP | Automatic Liquid Packaging, Inc. | JOL | Class II | 2000-10-25 |
| K003091 | MEDLINE STERILE VINYL EXAM GLOVES, POWDER FREE, YELLOW | Medline Industries, Inc. | LYZ | Class I | 2000-10-24 |
| K002975 | DERMAGRIP POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE STERILE, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL EXTRACTABL | Wrp Specialty Products Sdn. Bhd. | LYY | Class I | 2000-10-24 |
| K002492 | SIMPLICITY SOFT INFUSION SET | Sterling Medivations, Inc. | FPA | Class II | 2000-10-24 |
| K000838 | DIGITCARE POWDER FREE COATED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | P.T. Healthcare Glovindo | LYY | Class I | 2000-10-23 |
| K994276 | BIOPRO, NITRILON, CORRECT TOUCH- NITRILE POWDERED EXAMINATION GLOVES (GREEN/ PURPLE) | Biopro (M) Sdn Bhd | LZA | Class I | 2000-10-20 |
| K002814 | DISPOSBABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR | Shanghai PM Plastics Enterise Co., Ltd. | LYZ | Class I | 2000-10-20 |
| K994281 | BIOPRO, NITRILE, CORRECT TOUCH NITRILE POWDER FREE EXAMINATION GLOVES (GRREN, PURPLE) | Biopro (M) Sdn Bhd | LZA | Class I | 2000-10-20 |
| K003225 | SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE | Baxter Healthcare Corp | FPA | Class II | 2000-10-19 |
| K003010 | SPIRIT ACUPUNCTURE NEEDLE | United Pacific Co., Ltd. | MQX | Class II | 2000-10-19 |
| K002471 | JETCAN HUBER NEEEDLE SET | Pfm Produkte Fur Die Medizin AG | FPA | Class II | 2000-10-19 |
| K001795 | THE AVITRO LLC, 10 AND 100 USO UNITS/ML HEPARIN SODIUM VAFD | Avitro, LLC | FOZ | Class II | 2000-10-19 |
| K000632 | 0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE | Avitro, LLC | FOZ | Class II | 2000-10-19 |
| K002921 | SUREONE INSULIN SYRINGE | Hosuk Co., Ltd. | FMF | Class II | 2000-10-18 |
| K002870 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR | Shanghai PT Plastics Enterprise Company, Ltd. | LYZ | Class I | 2000-10-16 |
| K002922 | OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (200 MICROGRAMS OR LESS) | Omnigrace (Thailand) , Ltd. | LYY | Class I | 2000-10-16 |
| K002562 | PACIFIER THERMOMETER MODELS VT-901F, VT901C | Valeo Corp. | FLL | Class II | 2000-10-13 |
| K002180 | SIMPLICITY DISPOSABLE PEN NEEDLE | Sterling Medivations, Inc. | FMI | Class II | 2000-10-13 |
| K002745 | VINYL EXAMINATION GLOVES, POWDER FREE, BLUE COLOR | Arista Latindo Industrial Ltd. P.T | LYZ | Class I | 2000-10-12 |
| K002746 | VINYL EXAMINATION GLOVES, POWDER FREE, VANILLA COLOR | Arista Latindo Industrial Ltd. P.T | LYZ | Class I | 2000-10-11 |
| K002355 | ATOM INFA WARMER V-505 | Atom Medical Corp | FMT | Class II | 2000-10-10 |
| K002568 | POLYMER COAT, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | Smart Glove Corp. Sdn Bhd | LYY | Class I | 2000-10-03 |
| K002213 | BULL'S-EYE DISPOSABLE NEEDLE RECAPPING AID | Hunter Research Laboratories, Inc. | FMI | Class II | 2000-10-03 |
| K002770 | IBIS CHEMO-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM, MODEL 700-08-10,700-08-11,700-08-12,700-08-15,700-08-16,735-08-10 | Hdc Corp. | LJT | Class II | 2000-09-26 |
| K002414 | PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE | Fisher & Paykel Healthcare, Ltd. | LBI | Class II | 2000-09-25 |
| K001874 | PERIPHERALLY INSERTED CENTRAL CATHETER | Utah Medical Products, Inc. | LJS | Class II | 2000-09-25 |
| K001901 | POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE CATHETER, MODEL 3134135 | C.R. Bard, Inc. | LJS | Class II | 2000-09-19 |
| K002073 | PAIN CARE 3000 | Breg, Inc. | MEB | Class II | 2000-09-19 |
| K001175 | SERAGARD VASCULAR ACCESS PATCH | Platinum Services, Inc. | FMI | Class II | 2000-09-18 |
| K994420 | POWDER FREE LATEX EXAMINATION PATIENT GLOVES | Purna Bina Sdn Bhd | LYY | Class I | 2000-09-18 |
| K001599 | ACTI-FLEX IV ADMINISTRATION SET | R-Group Intl. | FPA | Class II | 2000-09-18 |
| K002679 | 6060 MULTI-THERAPY PUMP, MODEL 2M9832; 6060 EPIDURAL PUMP, MODEL 2L9351 | Baxter Healthcare Corp | FRN | Class II | 2000-09-18 |
| K000138 | MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERFREE | Industrial Clothings, Ltd. | LZA | Class I | 2000-09-13 |
| K000141 | MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDERED | Industrial Clothings, Ltd. | LYY | Class I | 2000-09-13 |
| K000145 | MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDER FREE | Industrial Clothings, Ltd. | LZA | Class I | 2000-09-13 |
| K000139 | MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDERED | Industrial Clothings, Ltd. | LZA | Class I | 2000-09-13 |
| K002087 | BESTEX POWDER-FREE LATEX EXAM GLOVES WITH LABELING CLAIM. (50 MICROGRAMS OR LESS) | Qingdao Bestex Rubber & Plastic Products Co., Ltd. | LYY | Class I | 2000-09-13 |
| K002701 | POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM. (50 MICROGRAMS OR LESS) | Alliance Rubber Products Sdn. Bhd. | LYY | Class I | 2000-09-13 |
| K000142 | MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDER FREE | Industrial Clothings, Ltd. | LYY | Class I | 2000-09-13 |
| K000143 | MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERED | Industrial Clothings, Ltd. | LZA | Class I | 2000-09-13 |
| K002448 | LATEX EXAMINATION GLOVES, POWDERED, (CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM). | Oon Corp. Resources | LYY | Class I | 2000-09-11 |
| K002739 | INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K | Baxter Healthcare Corp | MEA | Class II | 2000-09-11 |
| K001461 | TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET | Biometrix , Ltd. | KPE | Class II | 2000-09-11 |
| K002111 | RUBBERCARE POLYMER-COATED POWDERED LATEX EXAMINATION GLOVES/GUARDIAN POLYMER-COATED POWDERED EXAMINATION GLOVES. CONTAI | Perusahaan Pelindung Getah (M) Sdn Bhd | LYY | Class I | 2000-09-08 |
| K002579 | DERMAGRIP POWDERFREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS) | Wrp Specialty Products Sdn. Bhd. | LYY | Class I | 2000-09-08 |
| K000997 | ZORTRAN DETECTOR | Lucent Medical Systems | FOZ | Class II | 2000-09-07 |
| K001342 | P.O.P. PAIN KIT | Post Operative Pain Management | MEB | Class II | 2000-09-07 |
| K001872 | I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411 | Codan US Corp. | FPA | Class II | 2000-09-07 |
| K002380 | INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM | Baxter Healthcare Corp | FRN | Class II | 2000-09-05 |
| K001300 | D. R. MEDICAL CONTROLLED PRESSURE GARMENTS | Confection Medicale D.R., Inc. | DWL | Class II | 2000-08-30 |
| K002138 | PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380 | Maersk Medical A/S | FPA | Class II | 2000-08-29 |
| K002401 | CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION) | Advanced Sterilization Products | MED | Class II | 2000-08-29 |
| K001731 | AVID-NIT LOSS OF RESISTANCE SYRINGE | Avid Medical, Inc. | FMF | Class II | 2000-08-29 |
| K002434 | PALM PUMP | Sorenson Medical, Inc. | MEA | Class II | 2000-08-23 |
| K993950 | CECILIA PENGUIN MULTI-USE THERMOMETER, MODEL HP-ETO9999 | Nien Made Electrnics Corp. | FLL | Class II | 2000-08-23 |
| K000355 | 3M COMPLY 1249 LIQUID PERACETIC ACID CHEMICAL INDICATOR | Minnesota Mining and Mfg. Co. | JOJ | Class II | 2000-08-23 |
| K002065 | PATIENT LATEX POLYMER COATED POWDER-FREE GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GR | Comfort Rubber Gloves Industries Sdn. Bhd. | LYY | Class I | 2000-08-22 |
| K002340 | VINYL EXAMINATION GLOVE, POWDER-FREE, YELLOW | Glormed Intl., Inc. | LYZ | Class I | 2000-08-22 |
| K000969 | MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DA1 | Microlife Corp. | FLL | Class II | 2000-08-22 |
| K001829 | MINIMED PARADIGM INSULIN PUMP, MODEL 511 | Minimed, Inc. | FRN | Class II | 2000-08-18 |
| K001827 | PARADIGM SOF-SET MICRO QR, MODELS 324 AND 325 | Minimed, Inc. | FPA | Class II | 2000-08-18 |
| K001832 | PARADIGM SOF-SET ULTIMATE QR, MODELS 317 AND 318 | Minimed, Inc. | FPA | Class II | 2000-08-18 |
| K001828 | PARADIGM 1.5ML RESERVOIR, MODEL 326 | Minimed, Inc. | FRN | Class II | 2000-08-18 |
| K993042 | MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT | Medivators, Inc. | MED | Class II | 2000-08-17 |
| K002314 | LATEX PATIENT EXAMINATION GLOVES POWDERED WITH PROTEIN CONTENT LABELING CLAIM; 100 MICROGRAM OR LESS OF TOTAL WATER EXTR | Perusahaan Getah Asas Sdn. Bhd. | LYY | Class I | 2000-08-17 |
| K001106 | MASTERSITE NEEDLELESS LUER ACTIVATED IV CONNECTOR, MODEL MS 1000 | Creative Plastic Technology | FPA | Class II | 2000-08-16 |
| K002220 | NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE | Shanghai Champion Plastic Products Co., Ltd. | LZA | Class I | 2000-08-15 |
| K002218 | NITRILE EXAM GLOVE, POWDER-FREE, COLOR BLUE | Shanghai Champion Plastic Products Co., Ltd. | LZA | Class I | 2000-08-15 |
| K000685 | CHARTER MEDICAL NEONATAL SYRINGE SET | Charter Medical, Ltd. | BRZ | Class II | 2000-08-15 |
| K001572 | NEOLUS NEEDLE | Terumo Europe N.V. | FMI | Class II | 2000-08-14 |
| K002321 | PAIN CARE 2000L | Breg, Inc. | MEB | Class II | 2000-08-14 |
| K002112 | RUBBERCARE POLYMER-CHLORINATED POWDER-FREE GUARDIAN POLYMER-CHLORINATED POWDER-FREE | Perusahaan Pelindung Getah (M) Sdn Bhd | LYY | Class I | 2000-08-14 |
| K001604 | DANA DIABECARE | Sooil Development Co., Ltd. | LZG | Class II | 2000-08-14 |
| K994124 | NIPROTECT POWDER-FREE NITRILE EXAMINATION GLOVES | Mapa Professional | LZA | Class I | 2000-08-11 |
| K002114 | RUBBERCARE GUARDIAN POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVES: CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER | Perusahaan Pelindung Getah (M) Sdn Bhd | LYY | Class I | 2000-08-11 |
| K002216 | NITRILE EXAMINATION GLOVE, PRE-POWDERED, COLOR WHITE | Shanghai Champion Plastic Products Co., Ltd. | LZA | Class I | 2000-08-11 |
| K002217 | NITRILE EXAM GLOVE, POWDER-FREE, COLOR WHITE | Shanghai Champion Plastic Products Co., Ltd. | LZA | Class I | 2000-08-11 |
| K000913 | POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) | Handsafe Products Sdn. Bhd. | LYY | Class I | 2000-08-10 |
| K002006 | LIFESHIELD ADDITIVE PIERCING PIN | Abbott Laboratories | FPA | Class II | 2000-08-10 |
| K002015 | SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES | Shijiazhuang Great Vision Plastic Products Co., LT | LYZ | Class I | 2000-08-09 |
| K002012 | SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES | Shijiazhuang Great Vision Plastic Products Co., LT | LYZ | Class I | 2000-08-09 |
| K001764 | HOTLINE 2 FLUID WARMER | Sims Level 1, Inc. | LGZ | Class II | 2000-08-09 |
| K983299 | ALLEGIANCE GENESIS CONTAINER SYSTEM | Allegiance Healthcare Corp. | FRG | Class II | 2000-08-04 |
| K993052 | VYGON 2 FR EPICUTANEO PUR-CATHETER | Vygon Corp. | LJS | Class II | 2000-08-03 |
| K993442 | VYGON LIFECATH-PICC (PUR) CATHETERS (SINGLE AND DOUBLE LUMEN 3FR, 4FR, 4.5FR, AND 5FR) | Vygon Corp. | LJS | Class II | 2000-08-03 |
| K993524 | ADVANTIS ASC INFUSION PUMP AND ADMINISTRATION SETS | Alaris Medical Systems, Inc. | FRN | Class II | 2000-08-01 |
| K001690 | PROTECTIV SAFETY BLOOD COLLECTION NEEDLE | Johnson & Johnson Medical, Inc. | FMI | Class II | 2000-07-31 |
| K002176 | NON-STERILE POWDER FREE PINEAPPLE SCENTED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS LE | Sgmp Co., Ltd. | LYY | Class I | 2000-07-31 |
| K002175 | NON-STERILE POWDER FREE BUBBLE-GUM SCENTED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR | Sgmp Co., Ltd. | LYY | Class I | 2000-07-31 |
| K002211 | COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP 2M8151 | Baxter Healthcare Corp | FRN | Class II | 2000-07-28 |
| K000050 | TOP QUALITY CHLORINATED-POWDERFREE EXAMINATION GLOVES | Top Quality Mfg., Inc. | LYY | Class I | 2000-07-27 |
| K001616 | MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE | Abbott Laboratories | FOZ | Class II | 2000-07-27 |
| K001739 | POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN P | Allegiance Healthcare Corp. | LYY | Class I | 2000-07-27 |
| K001836 | NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR WHITE | Shanghai Poseidon Plastic Products Co., Ltd. | LZA | Class I | 2000-07-26 |
15,723 clearances in the General Hospital panel. Data: openFDA.