Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 34
- Latest Decision
- 1990-06-22
Clearances · page 112 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K902459 | LATEX EXAMINATION GLOVES | Yue XI State Farms Latex Products United Corp. | LYY | Class I | 1990-06-22 |
| K901458 | NUTRICARE ENFUTEC 1000 ENTERAL FEEDING PUMP | Clinical Systems, Inc. | LZH | Class II | 1990-06-22 |
| K902521 | WEEVAC 6 INFANT EVACUATION STRETCHER | W. Murphy Ent., Inc. | FPP | Class I | 1990-06-22 |
| K902010 | VISI - STICK OPHTHALMIC SUTURE RETAINER TAPE | Visitec Co. | KGX | Class I | 1990-06-20 |
| K900151 | INVACARE EXTENDED CARE NURSING HOME BED | Invacare Corp. | FNL | Class II | 1990-06-18 |
| K901729 | SAF-T CLIK I.V. IN-LINE CONNECTOR & EXTENSION SET | Ryan Medical, Inc. | FPA | Class II | 1990-06-18 |
| K900116 | DESERET OPTIMA INTRAVASCULAR CATHETER | Deseret Medical, Inc. | FOZ | Class II | 1990-06-18 |
| K901508 | RETRAX SAFETY SYRINGE | Retrax, Inc. | FMF | Class II | 1990-06-14 |
| K901046 | VERSA-LOCK(TM) UNIVERSAL NEEDLE CONNECTOR | Vlv Associates, Inc. | FPA | Class II | 1990-06-08 |
| K901081 | PRO-LOCK(TM) SHIELDING NEEDLE CONNECTOR ASSEMBLY | Vlv Associates, Inc. | FPA | Class II | 1990-06-08 |
| K901411 | CHEMOPLUS GLOVE | Biosafety Systems, Inc. | LYY | Class I | 1990-06-07 |
| K902282 | ULTRA.SPEC NON-STERILE LATEX EXAMINATION GLOVE | Ncl Corp. | LYY | Class I | 1990-06-07 |
| K901203 | HYPODERMIC SYRINGE LUER LOK | Ware-Medics Glass Works, Inc. | FMF | Class II | 1990-06-06 |
| K902182 | MODIFIED STERILE LATEX EXAMINATION GLOVES | Aladan Corp. | LYY | Class I | 1990-06-01 |
| K900980 | LATEX EXAMINATION GLOVES | Sinochem (Usa), Inc. | LYY | Class I | 1990-06-01 |
| K902181 | MODIFIED NON-STERILE LATEX EXAMINATION GLOVES | Aladan Corp. | LYY | Class I | 1990-06-01 |
| K896779 | CT-1000A SYSTEM | Bio-Monitor, Inc. | FLL | Class II | 1990-06-01 |
| K901749 | TABA PATIENT EXAMINATION GLOVES | R.S.T. Corp. | LYY | Class I | 1990-05-30 |
| K896848 | LIFT MASTER PATIENT LIFT | Henry Enterprises, Inc. | FNG | Class II | 1990-05-29 |
| K901376 | MAYFLOWER BRAND PATIENT EXAMINATION GLOVES | Kai FU Trading Co. | LYY | Class I | 1990-05-29 |
| K895436 | MODIFIED MINIMED III INFUSION PUMP | Medtronic Minimed | FRN | Class II | 1990-05-24 |
| K896800 | IRRIGATION TRAY | Westmark, Sterile Packing Systems, Inc. (Sps) | KYZ | Class I | 1990-05-24 |
| K900857 | NON STERILE PARENTERAL SUPPLY KIT | Intermed, Inc. | FMF | Class II | 1990-05-22 |
| K893071 | PATIENT EXAM GLOVES (MFG. KOON SENG) | Innovative Medical Suppliers | LYY | Class I | 1990-05-21 |
| K900127 | FERRIS HYDROPHILIC DRESSING (ADD'L INDICATIONS) | Ferris Mfg. Corp. | KMF | Class I | 1990-05-18 |
| K901855 | LATEX PATIENT EXAMINATION GLOVE | Tower Marketing Sdn. Bhd. | LYY | Class I | 1990-05-18 |
| K892305 | PATIENT EXAMINATION GLOVES (LATEX) | Hemipan Trading & Mfg. Co. (P) , Ltd. | LYY | Class I | 1990-05-18 |
| K900873 | PEDIATRIC HOSPITAL BED | Hospital Supply Co., Inc. | FMS | Class II | 1990-05-18 |
| K900687 | SYRINGE DISPOSAL SYSTEM | National Syringe Disposal, Inc. | FMF | Class II | 1990-05-18 |
| K902017 | LATEX PATIENT EXAMINATION GLOVES | Taksin Rubber Industries Co., Ltd. | LYY | Class I | 1990-05-18 |
| K900872 | WHEELED STRETCHER | Hospital Supply Co., Inc. | FPO | Class II | 1990-05-18 |
| K900909 | IN-LINE VIAL CONNECTION SITE | Baxter Healthcare Corp | FPA | Class II | 1990-05-18 |
| K901903 | PATIENT EXAMINATION GLOVES | Southland Products Co., Ltd. | LYY | Class I | 1990-05-18 |
| K900119 | LATEX PATIENT EXAMINATION GLOVES | Cen Tex Industrial Co., Ltd. | LYY | Class I | 1990-05-18 |
| K895735 | DESERET MULTILUMEN SUBCLAVIAN CATHETER | Deseret Medical, Inc. | LYY | Class I | 1990-05-18 |
| K893072 | PATIENT EXAM GLOVES (MFG. SUN FLOWER GLOVE CO.) | Innovative Medical Suppliers | LYZ | Class I | 1990-05-18 |
| K900888 | LOCKBOX | Pharmacia Deltec, Inc. | FRN | Class II | 1990-05-15 |
| K901321 | SHARP-SAFE, BIODEGRADEABLE,DISP., NEEDLE DISP. BOX | Sharp Safe, Inc. | LDQ | 1990-05-11 | |
| K896422 | BURRON AMBULATORY DRUG DELIVERY SYSTEM | Burron Medical, Inc. | FRN | Class II | 1990-05-09 |
| K901761 | STERILE SUCTION TUBING SET | Acacia Laboratories, Inc. | BYY | Class II | 1990-05-07 |
| K893215 | VITAJET(INSULIN JET INJECTION DEVICE) | Vitajet Industriae Comercioltda. | KZE | Class II | 1990-05-07 |
| K900651 | TS-1800 MEDICATION TRANSFER SPIKE | The Medi-Dose Group | FPA | Class II | 1990-05-07 |
| K900735 | MODEL 130 AUTOMATIC HEIGHT ADJUST (AHA) INCUBATOR | Preemicare Corp. | FMZ | Class II | 1990-05-02 |
| K896544 | MD2 PERSONAL INFUSION SYSTEM | Norfolk Medical Products, Inc. | FRN | Class II | 1990-05-02 |
| K901750 | LATEX PATIENT EXAMINATION GLOVES | Haikou Latex Factory | LYY | Class I | 1990-05-02 |
| K901486 | WEINSTEIN STYLE INSTRUMENT HOLDER | David Ayres Medical Co. | LDQ | 1990-05-02 | |
| K900110 | OPERAND* LUBRICATING JELLY | General Medical Co. | KMJ | Class I | 1990-05-02 |
| K900187 | ADVANCE CONTRAST MEDIA SETS (VARYING LENGTH) | Advance Medical Designs, Inc. | FPA | Class II | 1990-05-01 |
| K900188 | ADVANCE ADMINISTRATION SETS (VARYING LENGTH) | Advance Medical Designs, Inc. | FPA | Class II | 1990-05-01 |
| K901629 | CHEM-SLEEVE | Haz-Med, Inc. | KME | Class I | 1990-04-27 |
| K900643 | FLUID SOAKERSHIELD | Infection Control Products, Inc. | KME | Class I | 1990-04-25 |
| K896881 | LATEX DENTAL & EXAMINATION GLOVES | American Intl. Health Industries P.R., Inc. | LYY | Class I | 1990-04-25 |
| K896598 | STRATO INDWELLING CATHETER | Strato Medical Corp. | LJS | Class II | 1990-04-25 |
| K901116 | STERILE LATEX PATIENT EXAMINATION GLOVES | Medi Tex, Inc. | LYY | Class I | 1990-04-25 |
| K897168 | EPICUTANEO-CAVA CATHETER CODE 2184 | Vygon Corp. | LJS | Class II | 1990-04-23 |
| K900671 | HARE EMERGENCY STRETCHER WITH WHEELS | Dyna Corp. | FPP | Class I | 1990-04-23 |
| K900670 | HARE EMERGENCY STRETCHER | Dyna Corp. | FPP | Class I | 1990-04-23 |
| K901608 | HPI POWDER FREE NON-STERILE EXAMINATION GLOVES | Hpi, Inc. | LYY | Class I | 1990-04-20 |
| K896752 | LATEX EXAMINATION GLOVES | Aquatic Import & Export Corp. | LYY | Class I | 1990-04-19 |
| K900585 | TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP | Baxa Corp., Sub. of Cook Group, Inc. | LHI | Class II | 1990-04-18 |
| K901213 | LATEX EXAMINATION GLOVES | United Orient, Inc. | LYY | Class I | 1990-04-18 |
| K895030 | LIFE-LINE(TM) VASCULAR ACCESS SYSTEM | Medical Engineering and Development Institute | LJT | Class II | 1990-04-17 |
| K896041 | GESCO DUAL LUMEN UMBILICATH II-DL | Gesco Intl., Inc. | FOS | Class II | 1990-04-17 |
| K901155 | DUODERM* CONTROL GEL FORMULA BORDER DRESSING | Convatec, A Division of E.R. Squibb & Sons | KMF | Class I | 1990-04-16 |
| K894090 | PATIENT EXAMIN GLOVES(MFG: SHANGHAI FACTORY) | Everbest Machinery (U.S.A.) Co. , Ltd. | LYY | Class I | 1990-04-16 |
| K900447 | DUODERM* ADHESIVE COMPRESSION BANDAGE | Convatec, A Division of E.R. Squibb & Sons | KGX | Class I | 1990-04-13 |
| K896531 | NOVADERM | Syncare Corp. | KMF | Class I | 1990-04-13 |
| K900699 | FLO-GARD 6300 BLOOD PUMPING INDICATION | Baxter Healthcare Corp | FRN | Class II | 1990-04-10 |
| K901148 | LATEX EXAMINATION GLOVES | Pt. Scitech Industries | LYY | Class I | 1990-04-09 |
| K901479 | PATIENT EXAMINATION GLOVES | Hexza World Trade Sdn. Bhd. | LYY | Class I | 1990-04-09 |
| K895734 | DESERET INTRAVASCULAR CATHETER | Deseret Medical, Inc. | FOZ | Class II | 1990-04-09 |
| K901136 | LATEX EXAMINATION GLOVES | Qilu (China) Good Luck Chemical Fibers, Inc. | LYY | Class I | 1990-04-09 |
| K900790 | PROTEX LATEX EXAMINATION GLOVE | Seyen Intl., Inc. | LYY | Class I | 1990-04-05 |
| K894893 | POINT CHECKER COLOR STRIP THERMOMETER | Kyowa Medex Co., Ltd. | FQZ | Class I | 1990-04-05 |
| K900871 | ALTERNATING PRESSURE PUMP AND PAD SYSTEM | Three Bears Intl. | FNM | Class II | 1990-04-04 |
| K893802 | PROVIEW SELF-SEALING STERILIZATION POUCH | Cottrell, Ltd. | KCT | Class II | 1990-04-04 |
| K900204 | AVI MODEL 840 DUAL CHANNEL INFUSION PUMP | 3M Company | FRN | Class II | 1990-04-03 |
| K897125 | ATRIUM 2000, CHEST DRAIN | Atrium Medical Corp. | KDQ | Class II | 1990-03-30 |
| K896759 | PB PLUS LEAD LATEX GLOVES | Sistem Med-Pro (M) Sdn Bhd | LZC | Class I | 1990-03-27 |
| K900352 | LATEX EXAM GLOVES (SHANGHAI RONGTONG LATEX GLOVES) | Sinochem (Usa), Inc. | LYY | Class I | 1990-03-27 |
| K900981 | INTRAVENOUS STAND OR IV STAND | Travl-Med Infusion Device Transport System | FOX | Class I | 1990-03-27 |
| K900933 | PROTEX LATEX EXAMINATION GLOVES | Seyen Intl., Inc. | LYY | Class I | 1990-03-27 |
| K896938 | EPVC PATIENT EXAMINATION GLOVE | United Orient, Inc. | LYZ | Class I | 1990-03-27 |
| K900057 | LIFECARE(R) 175 INFUSER | Abbott Laboratories | FRN | Class II | 1990-03-27 |
| K897081 | ANSELL CONFORM GREEN EXAMINATION GLOVES | Ansell, Inc. | LYZ | Class I | 1990-03-26 |
| K896990 | PHARMULATOR | Acacia, Inc. | LHI | Class II | 1990-03-23 |
| K897054 | CLINICAL MERCURY THERMOMETER | Cypress Medical Products, Ltd. | FLK | Class II | 1990-03-22 |
| K897105 | CHEMO-SHIELD | Vision Plastics, Inc. | FMF | Class II | 1990-03-19 |
| K895195 | CHEMO-TOUCH | Medical Resources, Ltd. | LZC | Class I | 1990-03-15 |
| K897096 | MODEL 404A I.V. INFUSION PUMP ANALYZER | Dynatech/Nevada, Inc. | FRN | Class II | 1990-03-15 |
| K894650 | Q-PORT SYSTEM KIT | Quinton, Inc. | LJT | Class II | 1990-03-12 |
| K895781 | ANSELL E.P. EXTRA-PROTECTION EXAMINATION GLOVES | Ansell Intl. | LZC | Class I | 1990-03-09 |
| K893606 | PATIENT EXAMINATION GLOVES | Aukland Mfg., Inc. | LZA | Class I | 1990-03-09 |
| K900868 | STERILE LATEX EXAMINATION GLOVE | Sri Johani Sdn. Bhd. | LYY | Class I | 1990-03-09 |
| K900644 | I.V. FREEDOM CLIP | Infection Control Products, Inc. | FPA | Class II | 1990-03-09 |
| K900149 | POWDER-FREE VINYL GLOVES | Good Glove Corp. | LYZ | Class I | 1990-03-09 |
| K900811 | LATEX PATIENT EXAMINATION GLOVES | Kenwell International , Ltd. | LYY | Class I | 1990-03-09 |
| K900869 | NON-STERILE LATEX PROCEDURE GLOVE | Sri Johani Sdn. Bhd. | LYY | Class I | 1990-03-09 |
| K896527 | POWDER-FREE DANTEX VINYL EXAMINATION GLOVES | Dan Co., Ltd. | LYZ | Class I | 1990-03-08 |
| K895941 | PATIENT EXAMINATION GLOVES (LATEX) | Gim'S Trading Corp. | LYY | Class I | 1990-03-08 |
15,723 clearances in the General Hospital panel. Data: openFDA.