Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 27
- Latest Decision
- 2001-06-07
Clearances · page 65 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K011377 | NON-STERILE POWDER-FREE BLUE LATEX EXAMINATION GLOVES, WITH AND WITHOUT BUBBLEGUM SCENTING & A PROTEIN LABELING CLAIM (5 | Sgmp Co., Ltd. | LYY | Class I | 2001-06-07 |
| K011071 | PARADIGM QUICK-SET INFUSION SET | Maersk Medical A/S | FPA | Class II | 2001-06-07 |
| K010866 | TEMP-A-SURE | Homecare Technologies , Ltd. | FLL | Class II | 2001-06-06 |
| K010856 | STERILE BRIGHTWAY BRAND POWER-FREE, LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) TESTED | Brightway Holdings Sdn. Bhd. | LYY | Class I | 2001-06-06 |
| K011413 | POWDER-FREE VINYL EXAM GLOVE, YELLOW | Heyuan Hongli Industries, Inc. | LYZ | Class I | 2001-06-05 |
| K011580 | SIMPLICITY SOFT QD SILVER INFUSION SET | Sterling Medivations, Inc. | FPA | Class II | 2001-06-05 |
| K011414 | POWDERED VINAL EXAM GLOVES | Heyuan Hongli Industries, Inc. | LYZ | Class I | 2001-06-05 |
| K011563 | POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM | U.O.P. Rubber Products Sdn Bhd | LYY | Class I | 2001-06-05 |
| K011442 | ABBOTT PLUM A+INFUSION PUMP, MODEL 11971 | Abbott Laboratories | FRN | Class II | 2001-06-05 |
| K003543 | STRYKER PAINPUMP PCA | Stryker Instruments | FRN | Class II | 2001-06-05 |
| K010824 | PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT | Science Incorporated | MEB | Class II | 2001-06-05 |
| K011587 | SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMP | Entracon Corp. | LZH | Class II | 2001-06-01 |
| K003741 | JET SYRINGE MODEL-100500 | Equidyne Systems, Inc. | KZE | Class II | 2001-06-01 |
| K010961 | X-TENDA CUFF POWDER FREE NON-STERILE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | Ansell Healthcare Products, Inc. | LYY | Class I | 2001-05-31 |
| K011412 | POWDER-FREE VINYL EXAM GLOVES | Heyuan Hongli Industries, Inc. | LYZ | Class I | 2001-05-31 |
| K010865 | AMSCO CENTURY MEDIUM STERILIZER, MODEL CENTURY | STERIS Corporation | FLE | Class II | 2001-05-31 |
| K011474 | POWDERED SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES | Shijiazhuang Junfei Plastic Products Co., Ltd. | LYZ | Class I | 2001-05-31 |
| K011369 | ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY) | Safety Syringes, Inc. | MEG | Class II | 2001-05-29 |
| K010279 | MEDISYSTEMS LUER ACCESS INJECTION SITE | Medisystems Corp. | FPA | Class II | 2001-05-29 |
| K011376 | EVERGREEN AND MULTIPLE PRIVATE LABELS NON-STERILE POWDERED LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN LABELING (200 | Yty Industry (Manjung) Sdn Bhd | LYY | Class I | 2001-05-25 |
| K010947 | SNOW LOTUS POWDER FREE LATEX EXAMINATION GLOVES WITH A PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | Beijing Reagent Latex Products Co., Ltd. | LYY | Class I | 2001-05-25 |
| K011186 | POWDER-FREE STERILE SYNTHETIC VINYL EXAMINATION GLOVES | Allegiance Healthcare Corp. | LYZ | Class I | 2001-05-25 |
| K011004 | NEEDLELOK HYPODERMIC NEEDLE PROTECTION | Diasol, Inc. | FMI | Class II | 2001-05-24 |
| K010818 | INFANT LIMB HOLDER, MODELS 306080 & 306081 | Skil-Care Corp. | FMQ | Class I | 2001-05-24 |
| K003187 | VACUCATH I.V. CATHETER INTRODUCTER | Auto/Cath Vascular Access, Inc. | FOZ | Class II | 2001-05-21 |
| K010958 | FISTULOK FISTULA NEEDLE PROTECTION | Diasol, Inc. | FMI | Class II | 2001-05-18 |
| K010644 | CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025 | Skil-Care Corp. | FMQ | Class I | 2001-05-18 |
| K011198 | SENICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL EXAMINATION GLOVE, SENSICARE ADVANTIX POWDER FREE POLYURETHANE DENTAL | Maxxim Medical, Inc. | LZA | Class I | 2001-05-17 |
| K011286 | POWDER-FREE NITRILE EXAM GLOVE, BLUE | Ningbo Yujiang Plastic & Rubber Co. , Ltd. | LZA | Class I | 2001-05-16 |
| K010881 | UNIGLOVE POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | N.S. Uni-Gloves Sdn. Bhd. | LYY | Class I | 2001-05-16 |
| K010566 | COLLEAGUE VOLUMETRIC INFUSION PUMP | Baxter Healthcare Corp | FRN | Class II | 2001-05-15 |
| K010197 | EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET | Exelint International, Co. | FPA | Class II | 2001-05-14 |
| K010803 | POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR | Hwa Teh Industrial Sdn. Bhd. | LYY | Class I | 2001-05-11 |
| K004018 | SKINGARD POLYCOAT GLOVE | Top Quality Mfg., Inc. | LYY | Class I | 2001-05-11 |
| K010879 | UNIGLOVE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | N.S. Uni-Gloves Sdn. Bhd. | LYY | Class I | 2001-05-10 |
| K011271 | POWDER-FREE LATEX EXAMINATION GLOVE, BLUE COLORED | Perusahaan Getah Asas Sdn. Bhd. | LYY | Class I | 2001-05-08 |
| K010825 | MEDLINE STERISET STERILIZATION CONTAINER | Medline | FRG | Class II | 2001-05-08 |
| K011120 | GLUCOPRO INFUSION SET, MODEL GPISXXXXXXXX SERIES | Nipro Diabetes Systems, Inc. | FPA | Class II | 2001-05-08 |
| K010863 | LAGLOVE BRAND NITROPRENE POWDER FREE EXAMINATION GLOVES (MADE OF NITRILE-NEOPRENE CO-POLYMER) | La Glove (M) Sdn. Bhd. | LZA | Class I | 2001-05-03 |
| K010483 | POWDERFREE COLORED LATEX EXAMINATION GLOVES (PINK, BLUE, GREEN, AND WHITE) WITH PROTEIN CONTENT LABELING CLAIM (50 MICR0 | Pt. Medisafe Technologies | LYY | Class I | 2001-05-03 |
| K011096 | ABBOTT ACCLAIM ENCORE, MODEL 12237 | Abbott Laboratories | FRN | Class II | 2001-05-01 |
| K003402 | WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION | Welcon, Inc. | JOL | Class II | 2001-05-01 |
| K011012 | POWDER FREE NITRILE EXAMINATION GLOVE | Contract Latex Dippers Sdn Bhd | LZA | Class I | 2001-05-01 |
| K002718 | ULTRA CARE 2 LATEX EXAMINATION GLOVES MADE FROM ALLOTEX (ENZYME TREATED) NATURAL RUBBER LATEX WITH A PROTEIN CONTENT LAB | Tillotson Healthcare Corp. | LYY | Class I | 2001-05-01 |
| K003812 | VACUETTE SPEEDY QUICK-RELEASE HOLDER | Greiner Vacuette North America, Inc. | FMI | Class II | 2001-04-30 |
| K010886 | SIMPLICITY WING INFUSION SET | Sterling Medivations, Inc. | FPA | Class II | 2001-04-30 |
| K010708 | APPLICATOR TIP/DUAL SPRAYER KIT | Interpore Cross Intl. | FMF | Class II | 2001-04-30 |
| K010627 | POWDER FREE VINYL PATIENT EXAMINATION GLOVES | Shijiazhuang Junfei Plastic Products Co., Ltd. | LYZ | Class I | 2001-04-24 |
| K010628 | POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES | Shijiazhuang Junfei Plastic Products Co., Ltd. | LYZ | Class I | 2001-04-23 |
| K003381 | SHIELDING NEEDLE HOLDER | U.S. Safety Syringes Co., Inc. | FMI | Class II | 2001-04-23 |
| K010626 | POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES | Shijiazhuang Junfei Plastic Products Co., Ltd. | LYZ | Class I | 2001-04-23 |
| K010788 | SIMPLICITY SOFT QD EASY INFUSION SET | Sterling Medivations, Inc. | FPA | Class II | 2001-04-20 |
| K011003 | SAFESTING AND SAFESTING HUB | Diasol, Inc. | FPA | Class II | 2001-04-20 |
| K010890 | BD ULTRA-FINE II INSULIN SYRINGE-MINI NEEDLE, MODEL 30G * 3/16 (5MM) | Becton, Dickinson and Co. | FMF | Class II | 2001-04-19 |
| K003521 | DISPO-MED 7.6 LITER SHARPS CONTAINER | Master Benefits, Inc. | FMI | Class II | 2001-04-19 |
| K010676 | SIMPLICITY WINGED QD INFUSION SET | Sterling Medivations, Inc. | FPA | Class II | 2001-04-18 |
| K010383 | TEMP SCAN | Tenghi Co., Ltd. | FLL | Class II | 2001-04-18 |
| K010647 | SIMPLICITY INFUSER INFUSION SET | Sterling Medivations, Inc. | FPA | Class II | 2001-04-13 |
| K000592 | UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET | Myco Medical Supplies, Inc. | FPA | Class II | 2001-04-12 |
| K010846 | SIMPLICITY SILVER SET SOFT INFUSION | Sterling Medivations, Inc. | FPA | Class II | 2001-04-12 |
| K010462 | AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) | Avita Corporation | FLL | Class II | 2001-04-11 |
| K003326 | FUNET AMY MAMA BODY THERMOMETER | Funai Radio & Communications Corp. | FLL | Class II | 2001-04-11 |
| K010767 | LIFEPORT VTX ACCESS SYSTEM,MODEL VTX 7000 SERIES | Horizon Medical Products, Inc. | LJT | Class II | 2001-04-10 |
| K010719 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, PURPLE COLOR | Perusahaan Getah Asas Sdn. Bhd. | LZA | Class I | 2001-04-10 |
| K010486 | POLYMER COATED POWDER-FREE GREY COLOR POLYCHLOROPRENE PATIENT EXAMINATION GLOVES | Pt. Medisafe Technologies | LZA | Class I | 2001-04-10 |
| K010671 | POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE | Tong Ruhn Medical Products Co., Ltd. | LYZ | Class I | 2001-04-09 |
| K010830 | POWDER FREE TEXTURED VINYL EXAMINATION GLOVES | General Gloves Corp. | LYZ | Class I | 2001-04-09 |
| K010924 | MODIFICATION TO PLUM XL INFUSION PUMP | Abbott Laboratories | FRN | Class II | 2001-04-06 |
| K010377 | MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385 | Minimed, Inc. | KZH | Class II | 2001-04-05 |
| K010623 | RECONSTITUTION KIT & VIAL CONNECTOR | Bioject, Inc. | LHI | Class II | 2001-04-05 |
| K010829 | POWDER FREE ELASTIC VINYL EXAMINATION GLOVES | General Gloves Corp. | LYZ | Class I | 2001-04-05 |
| K003350 | HEALTH-PLUS, SANITEX, RELIANCE MULTIPLY POWDER FREE POLYMER AND NITRILE COATED (BLUE) | Pamitex Industries Sdn Bhd | LYY | Class I | 2001-04-05 |
| K010860 | LAGLOVE BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (GREEN/PURPLE) | La Glove (M) Sdn. Bhd. | LZA | Class I | 2001-04-03 |
| K010110 | POWDER-FREE NITRILE EXAMINATION GLOVES, WHITE | Shen Wei (Usa), Inc. | LZA | Class I | 2001-04-03 |
| K010861 | LAGLOVE BRAND COLORED POWDERED NITRILE EXAMINATION GLOVES(GREEN/PURPLE) | La Glove (M) Sdn. Bhd. | LZA | Class I | 2001-04-03 |
| K994381 | PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR | Raven Biological Laboratories, Inc. | FRC | Class II | 2001-03-30 |
| K010097 | POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) | Shen Wei (Usa), Inc. | LZA | Class I | 2001-03-30 |
| K010538 | PARSET NEEDLELESS PRIMARY SET FOR BLUNT CANNULA, A10003E, PARSET NEEDLELESS SECONDARY SET WITH BLUNT CANNULA, A14003E | Rd Medical Mfg., Inc. | FPA | Class II | 2001-03-30 |
| K003382 | SARSTEDT NEEDLE PROTECTOR | Sarstedt, Inc. | FMI | Class II | 2001-03-30 |
| K010663 | POWDERED SYNTHETIC VINYL PATIENT EXAM GLOVE | Tong Ruhn Medical Products Co., Ltd. | LYZ | Class I | 2001-03-30 |
| K002705 | EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400 | Baxa Corp. | LHI | Class II | 2001-03-28 |
| K010616 | DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A | Hmi Industries, Inc. | FRF | Class II | 2001-03-28 |
| K010356 | LATEX EXAMINATION GLOVES-POWDER FREE | Enzymic Technologies Sdn Bhd | LYY | Class I | 2001-03-27 |
| K010347 | LATEX EXAMINATION GLOVES-POWDERED, NONSTERILE | Enzymic Technologies Sdn Bhd | LYY | Class I | 2001-03-27 |
| K010222 | OHMEDA MEDICAL GIRAFFE INCUBATOR | Ohmeda Medical | FMZ | Class II | 2001-03-21 |
| K003553 | 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE | Bd Becton Dickinson Vacutainer Systems Preanalytic | FOZ | Class II | 2001-03-21 |
| K010224 | NPAC MULTI-USE THERMOMETER, MODEL TD400 | Norm Pacific Automation Corp. | FLL | Class II | 2001-03-18 |
| K010217 | 4 PORT, 4 WAY STOPCOCK | George Loo, MD | FMG | Class II | 2001-03-18 |
| K010103 | SURSHIELD WINGED INFUSION SET | Terumo Medical Corp. | FPA | Class II | 2001-03-15 |
| K010359 | INNOVO | Novo Nordisk A/S | FMF | Class II | 2001-03-14 |
| K010373 | SIMPLICITY SOFT Y INFUSION SET FOR USE WITH THE MINIMED INFUSION PUMPS AND MINIMED MEDICATION RESERVOIRS (MODEL MMT-103) | Sterling Medivations, Inc. | FPA | Class II | 2001-03-13 |
| K010495 | CENTURA PHOTOTHERAPY SPOTLIGHT | Medical Illumination International, Inc. | LBI | Class II | 2001-03-09 |
| K003908 | SEROJET | Bioject, Inc. | KZE | Class II | 2001-03-08 |
| K010426 | PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER | Sims Deltec, Inc. | LJT | Class II | 2001-03-08 |
| K002689 | SWABSITE SWABBABLE VALVE, MODEL 245000 | Quest Medical, Inc. | FPA | Class II | 2001-03-06 |
| K003864 | INJEX 50 SYSTEM | Equidyne Systems, Inc. | KZE | Class II | 2001-03-06 |
| K010188 | BD ECLIPSE HYPODERMIC NEEDLE | Bd Medical Systems | FMI | Class II | 2001-03-01 |
| K002827 | MAC ACUPUNCTURE NEEDLE | Haenglim Seowon Corp. | MQX | Class II | 2001-02-28 |
| K010077 | HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVES | Pwa Industries Sdn. Bhd. | LZA | Class I | 2001-02-28 |
| K010349 | DUAL LUMEN MIDLINE CATHETER | Catheter Innovations, Inc. | LJS | Class II | 2001-02-28 |
15,723 clearances in the General Hospital panel. Data: openFDA.