Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 22
- Latest Decision
- 2000-04-20
Clearances · page 69 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K001102 | PARSET PRIMARY SET WITH CHECK VALVE, MODEL A10002E | Rd Medical Mfg., Inc. | FPA | Class II | 2000-04-20 |
| K000953 | DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR | Shanghai Antares Industries, Inc. | LYZ | Class I | 2000-04-20 |
| K000868 | NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES | Sgmp Co., Ltd. | LZA | Class I | 2000-04-20 |
| K000455 | GETTIG GUARD | Gettig Pharmaceutical Instrument Co. | FMI | Class II | 2000-04-19 |
| K000223 | NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE | Phoenix Medical Technology, Inc. | LZA | Class I | 2000-04-14 |
| K000390 | VITAL SHIELD GOLD POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) | Sgmp Co., Ltd. | LYY | Class I | 2000-04-12 |
| K001008 | TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921 | Oriental System Technology, Inc. | FLL | Class II | 2000-04-12 |
| K000584 | POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | Shasta Asia Partners Gloves Manufacturing CO , Ltd. | LYY | Class I | 2000-04-12 |
| K000555 | TEKMEDIC POWDERED SINGLE-USE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN & POWDER LABEL CLAIM CONTAINS 70MGM OR LESS O | Tekmedic (M) Sdn Bhd | LYY | Class I | 2000-04-12 |
| K000391 | VITAL SHIELD GOLD POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | Sgmp Co., Ltd. | LYY | Class I | 2000-04-12 |
| K991677 | REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC (POWDERFREE) | London International Group, Inc. | LYY | Class I | 2000-04-12 |
| K993116 | A&D MEDICAL UT-101 LIFESOURCE DIGITAL EAR THEROMETER | A&D Engineering, Inc. | FLL | Class II | 2000-04-12 |
| K000125 | JET PORT PLUS CATHETER SYSTEM | Clinical Plastic Products SA | LJT | Class II | 2000-04-12 |
| K992553 | IQ CHAMBERS | Dormer Laboratories, Inc. | KXF | Class I | 2000-04-12 |
| K000670 | NITRILE EXAM GLOVE, POWDER FREE, BLUE | Shasta Asia Partners Gloves Manufacturing CO , Ltd. | LZA | Class I | 2000-04-12 |
| K000688 | UNIGLOVE NITRILE POWDERED EXAMINATION GLOVES | N.S. Uni-Gloves Sdn. Bhd. | LZA | Class I | 2000-04-12 |
| K994099 | VINYL PATIENT EXAMINATION GLOVES-PRE-POWDERED | Evergreen Medical Produts (Jingxing) Co., Ltd. | LYZ | Class I | 2000-04-12 |
| K000740 | ASAHI STERILE ACUPUNCTURE NEEDLE TYPE S | Asahi Iryoki Co., Ltd. | MQX | Class II | 2000-04-12 |
| K000441 | BODYGUARD | Vital Signs, Inc. | FMI | Class II | 2000-04-11 |
| K000652 | BETEL POWDER FREE LATEX EXAM GLOVES, CHLORINATED, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) | Betel Care Sdn. Bhd. | LYY | Class I | 2000-04-10 |
| K000828 | HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATION GLOVE | Pamitex Industries Sdn Bhd | LYY | Class I | 2000-04-07 |
| K000323 | NITRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDER FREE, NON STERILE | Siam Sempermed Corp., Ltd. | LZA | Class I | 2000-04-05 |
| K000872 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR | Shanghai Antares Industries, Inc. | LYZ | Class I | 2000-04-05 |
| K000235 | INSYTE CATHETER, INSYTE AUTOGUARD CATHETER | Becton Dickinson Infusion Therapy Systems, Inc. | FOZ | Class II | 2000-04-05 |
| K000330 | NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR), POWDER FREE, NON STERILE | Siam Sempermed Corp., Ltd. | LZA | Class I | 2000-04-05 |
| K000329 | NITRILE PATIENT EXAMINATION GLOVE POWDER FREE, NON STERILE | Siam Sempermed Corp., Ltd. | LZA | Class I | 2000-04-05 |
| K000725 | HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) | Hwa Teh Industrial Sdn. Bhd. | LYY | Class I | 2000-04-05 |
| K991383 | HYDROCISION DEBDRIDEMENT SYSTEM | Hydrocision, Inc. | FQH | Class II | 2000-03-31 |
| K000369 | VACUFLOW+ BLOOD COLLECTION SET, MODEL 52221/3/5; VACUFLOW+ WITH HOLDER BLOOD COLLECTION SET, MODEL 82021/3/5 WITH HOLDER | Medpro Technologies, Inc. | FMI | Class II | 2000-03-30 |
| K000671 | POWDERED LATEX EXAM GLOVES, PINK, WITH/WITHOUT STRAWBERRY SCENT, PROTEIN LABELING | Sgmp Co., Ltd. | LYY | Class I | 2000-03-29 |
| K992554 | SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES | Shijiazhuang Great Vision Plastic Products Co., LT | LYZ | Class I | 2000-03-29 |
| K994230 | ULTICARE DISPOSABLE SYRINGE | Ultimed, Inc. | FMF | Class II | 2000-03-24 |
| K000821 | ABBOTT GEMSTAR I.V. INFUSION PUMP - 7 THERAPY CONFIGURATION, 6 THERAPY CONFIGURATION, 1 THERAPY CONFIGURATION | Abbott Laboratories | FRN | Class II | 2000-03-24 |
| K000488 | VITAL SHIELD GOLD NON-STERILE POWDERED LATEX EXAM GLOVES BLUE, WITH AND/OR WITHOUT BUBBLEGUM SCENT, AND WITH PROTEIN LAB | Sgmp Co., Ltd. | LYY | Class I | 2000-03-20 |
| K993609 | SOLOGUARD LOCKING PLUS SYRINGE | Safeguard Medical Products, Inc. | MEG | Class II | 2000-03-17 |
| K000087 | MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR | The Kendal Co. | FOZ | Class II | 2000-03-17 |
| K000085 | PORTSETT | Portsett, Inc. | FMI | Class II | 2000-03-17 |
| K000077 | STERIS AMSCO MILLENNIUM STEAM STERILIZER | STERIS Corporation | FLE | Class II | 2000-03-17 |
| K000644 | SUPERGLOVES STERILE POWDERED LATEX EXAMINATION GLOVES | Supermax Glove Manufacturing Sdn Bhd | LYY | Class I | 2000-03-17 |
| K000502 | STEAM/EO RECORD CARD, MODEL CI 121 | Steritec Products Mfg Co, Inc. | JOJ | Class II | 2000-03-14 |
| K993024 | CELSITE IMPLANTABLE PORT WITH VALVED CATHETER | B. Braun of America, Inc. | LJT | Class II | 2000-03-13 |
| K000165 | NEXT STEP POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM | Ansell Perry | LYY | Class I | 2000-03-10 |
| K993805 | NITRI-CARE NITRILE POWDER-FREE STERILE MEDICAL EXAMINATION GLOVES (BLUE, CHERRY FLAVORED) | Best Manufacturing Company | LZA | Class I | 2000-03-10 |
| K992821 | SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES | Shijiazhuang Hongxiang Plastics Products Co., Ltd. | LYZ | Class I | 2000-03-10 |
| K000058 | BROTHERS POWDER-FREE VINYL EXAMINATION GLOVES | Kaohsiung Brothers Products Corp. | LYZ | Class I | 2000-03-10 |
| K000657 | LUER ACCESS UNIVERSAL VIAL ADAPTER | Baxter Healthcare Corp | FMI | Class II | 2000-03-08 |
| K993691 | ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER | Arrow Intl., Inc. | FOZ | Class II | 2000-03-08 |
| K982558 | BD PREEFILE NORMAL SALINE FLUSH SYRINGE FLUSH SYRINGE | Bd/Preefil | FOZ | Class II | 2000-03-08 |
| K994323 | KAWASUMI LABORATORIES PHILEBOTOMY SET | Kawasumi Laboratories Co., Ltd. | LHI | Class II | 2000-03-08 |
| K990831 | SUPERGUARD SAFETY SYRINGE | U.S. Safety Syringes Co., Inc. | MEG | Class II | 2000-03-08 |
| K994375 | HORIZON LIGHT | B.Braun Medical, Inc. | FRN | Class II | 2000-03-08 |
| K000482 | MODIFICATION TO AUTOJECT MINI | Owen Mumford, Ltd. | KZH | Class II | 2000-03-06 |
| K994429 | VENUSA, LTD. EXTENSION SET WITH FILTER | Venusa , Ltd. | FPA | Class II | 2000-03-03 |
| K994374 | SOAKER CATHETER | I-Flow Corp. | FRN | Class II | 2000-03-03 |
| K000387 | TERUMO NEEDLE WITH LOCKING SHEATH | Terumo Medical Corp. | FMI | Class II | 2000-03-02 |
| K993117 | SAFESKIN PFE-XTRA POWDER-FREE LATEX EXAMINATION GLOVES, PROTEIN CONTENT 50 MCG OR LESS, FOR USE WITH CHEMOTHERAPEUTIC AG | Safeskin Corp. | LYY | Class I | 2000-03-02 |
| K993811 | MULTISAFE POWDERED LATEX EXAMINATION GLOVES, NONSTERILE | Multisafe Sdn. Bhd. | LYY | Class I | 2000-03-02 |
| K000226 | DISPOSABLE POWDER FREE NITRILE EXAM GLOVES, WHITE COLOR | Sheen More Ent. Co., Ltd. | LZA | Class I | 2000-03-02 |
| K000343 | NAC Y-ADP | The Kipp Group | FPA | Class II | 2000-03-01 |
| K000152 | KIPPMED I.V. MANIFOLD | The Kipp Group | FPA | Class II | 2000-02-29 |
| K000367 | SECURMIX | Eurospital | LHI | Class II | 2000-02-29 |
| K000071 | SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES | Shijiazhuang Great Eagle Plastic Products Co., Ltd. | LYZ | Class I | 2000-02-29 |
| K993017 | PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGE | Shinchang Medical Co., Ltd. | FMF | Class II | 2000-02-25 |
| K993515 | MEDEFIL'S NORMAL SALINE FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE L | Medefil, Inc. | FOZ | Class II | 2000-02-25 |
| K000572 | E.N.S.I. SYRINGE | Tri-Ject Intl. Corp. | MEG | Class II | 2000-02-24 |
| K992290 | EXEL INJECTION PLUG WITH CAP | Exel Intl. | FPA | Class II | 2000-02-23 |
| K994275 | SIMS PORTEX ANESTHESIA CATHETER | Sims Portex, Inc. | FRN | Class II | 2000-02-22 |
| K000166 | SYNTHETIC (WHITE) VINAL POWDERED PATIENT EXAMINATION GLOVES | Shijiazhuang Great Eagle Plastic Products Co., Ltd. | LYZ | Class I | 2000-02-22 |
| K992539 | PERCUGUARD | Digit-Pro | LZB | Class I | 2000-02-18 |
| K000156 | SMART SHIELD NON-STERILE POWDER-FREE PEPPERMINT SCENTED GREEN LATEX EXAMINATION GLOVES | Shield Gloves Manufacturer (M) Sdn Bhd | LYY | Class I | 2000-02-18 |
| K000217 | ROYAL SHIELD NON-STERILE PURPLE (PINK/BLUE) COLORED POWDERED LATEX EXAM WITH PROTEIN LABELING CLAIM [<200 MCG OR LESS] W | Shield Gloves Manufacturer (M) Sdn Bhd | LYY | Class I | 2000-02-18 |
| K994432 | HWA & SILKTEX POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (140 MICROGRAMS OR LESS) | Hwa Teh Industrial Sdn. Bhd. | LYY | Class I | 2000-02-16 |
| K994314 | CASTLE SERIES 100HC STEAM STERILIZERS | Getinge/Castle, Inc. | FLE | Class II | 2000-02-16 |
| K992699 | NIPRO BLOOD COLLECTION NEEDLE | Nipro Medical Corp. | FMI | Class II | 2000-02-14 |
| K993995 | VEIN ENTRY INDICATOR DEVICE (VEID) | Vascular Technologies , Ltd. | FMF | Class II | 2000-02-14 |
| K000144 | NIPRO INSULIN SYRINGE | Nipro Medical Corp. | FMF | Class II | 2000-02-11 |
| K993184 | R1000 SERIES INSULIN PUMP | Animas Corp. | LZG | Class II | 2000-02-10 |
| K000090 | GUTHRIE PRIME POWDER-FREE CHLORINATED PATIENT EXAMINATION GLOVES | Guthrie Medicare Products (Melaka) Sdn Bhd | LYY | Class I | 2000-02-10 |
| K994196 | HORIZON MEDICAL PRODUCTS MICROPORT 2 PERIPHERAL ACCESS PORT SYSTEM | Horizon Medical Products, Inc. | LJT | Class II | 2000-02-10 |
| K000017 | PARSET SECONDARY ADMINISTRATION SET, LUERLOCK, MODEL A14001E, PARSET SECONDARY SECONDARY ADMINISTRATION SET, MODEL A1400 | Rd Medical Mfg., Inc. | FPA | Class II | 2000-02-10 |
| K993918 | HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVE (NATURAL RUBBER LATEX-NITRILE-CONSTRUCTION | Pamitex Industries Sdn Bhd | LYY | Class I | 2000-02-10 |
| K993832 | AUTODOSE INFUSION SYSTEM, MODEL AD4120, BE4210, S12050,100,200, FF0005, 10 | Tandem Medical, Inc. | MEB | Class II | 2000-02-09 |
| K993912 | AMBIDERM POWDER FREE LATEX EXAMINATION GLOVES (VIOLET, BLUE, GREEN AND PINK), WITH PROTEIN CONTENT LABELING CLAIM (50 MI | Latexx Partners, Inc. | LYY | Class I | 2000-02-09 |
| K994162 | POWERED DENTAL POWDERED EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (75 MICROGRAMS OR LESS) | Allegiance Healthcare Corp. | LYY | Class I | 2000-02-09 |
| K992979 | SHANGHAI POSEIDON POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW | Shanghai Poseidon Plastic Products Co., Ltd. | LYZ | Class I | 2000-02-09 |
| K994201 | RUBBERCARE POWDER-FREE, GUARDIAN POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) | Perusahaan Pelindung Getah (M) Sdn Bhd | LYY | Class I | 2000-02-07 |
| K994255 | LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE | Pt. Maja Agung Latexindo | LYY | Class I | 2000-02-07 |
| K993972 | DISPOSABLE INFUSION PUMP KIT | Biomet, Inc. | MEB | Class II | 2000-02-07 |
| K994131 | AMBIDERM POWDERFREE LATEX EXAMINATION GLOVES WITH A PROTEIN CLAIM OF 50 MICROGRAMS OR LESS PER GRAM (BLACK COLORED) | Medtaxx Partners | LYY | Class I | 2000-02-07 |
| K994222 | SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, BEIGE COLOR | Shijiazhuang Hongray Plastic Products Co., Ltd. | LYZ | Class I | 2000-02-07 |
| K994250 | TEKMEDIC POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | Tekmedic (M) Sdn Bhd | LYY | Class I | 2000-02-07 |
| K993876 | POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA | Shen Wei (Usa), Inc. | LZA | Class I | 2000-02-07 |
| K994206 | SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES, BEIGE COLOR | Shijiazhuang Hongray Plastic Products Co., Ltd. | LYZ | Class I | 2000-02-07 |
| K994136 | POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVES | Shanghai Champion Plastic Products Co., Ltd. | LYZ | Class I | 2000-02-03 |
| K993051 | VERSALET 7700 CARE CENTER, MODEL # 7700 | Hill-Rom Air-Shields | FMZ | Class II | 2000-02-03 |
| K994416 | POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE | Flexitech Sdn. Bhd. | LYY | Class I | 2000-02-03 |
| K994246 | OMNI GRACE NITRILE, BLUE, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED | Omnigrace , Ltd. | LZA | Class I | 2000-01-31 |
| K994354 | POLYMER COATED, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | Flexitech Sdn. Bhd. | LYY | Class I | 2000-01-31 |
| K000048 | SEALOUETTE FIBRIN SEALANT EXTENDED DROPLET APPLICATOR, MODEL TE-1 | Biosurgical Corp. | FMF | Class II | 2000-01-31 |
| K994082 | POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) (50 MICROGRAM OR LESS) | Besglove Medicare Sdn. Bhd. | LYY | Class I | 2000-01-28 |
15,723 clearances in the General Hospital panel. Data: openFDA.