Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 13
- Latest Decision
- 1989-09-12
Clearances · page 117 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K894335 | MODEL #535 PACU STRETCHER/BED & #530 ED/TRAUMA STR | Midmark Corp. | FMF | Class II | 1989-09-12 |
| K894972 | UNICARE LATEX EXAMINATION GLOVES | Pt. Indorub Nusaraya | LYY | Class I | 1989-09-12 |
| K893796 | DISPOSABLE VINYL (PVC) EXAMINATION GLOVES | Anmei Plastic & Rubber Products Co. , Ltd. | LYZ | Class I | 1989-09-12 |
| K893235 | LATEX EXAMINATION GLOVES | Quingdao Latex Factory | LYY | Class I | 1989-09-12 |
| K892035 | PATIENT EXAMINATION GLOVE (LATEX) | Fine Spring Ent. Co., Ltd. | LYY | Class I | 1989-09-12 |
| K893339 | LATEX EXAMINATION GLOVES | Kenmark Industrial Co., Ltd. | LYY | Class I | 1989-09-12 |
| K891575 | COMPAT ENTERAL FEED PUMP 199235 & 199240 | Sandoz Nutrition | LZH | Class II | 1989-09-12 |
| K894217 | SYRINGE TIP ADAPTOR | Acacia, Inc. | FMF | Class II | 1989-09-12 |
| K894842 | IMED GEMINI 12 NONVENTED Y-TYPE BLOOD/SOLUTION ADM | Imed Corp. | FPA | Class II | 1989-09-12 |
| K894177 | NEEDLE*LESS DRUG VIAL ADAPTER | Baxter Healthcare Corp | FMF | Class II | 1989-09-12 |
| K894995 | LATEX PATIENT EXAMINATION GLOVES | Orient Commercial Co., Ltd. | LYY | Class I | 1989-09-12 |
| K894979 | LATEX PATIENT EXAMINATION GLOVES | Tower Rubber Industries Sdn. Bhd. | LYY | Class I | 1989-09-12 |
| K893100 | VINYL EXAMINATION GLOVES | Tong Shiung Plastics Industry | LYZ | Class I | 1989-09-11 |
| K893932 | LATEX EXAMINATION GLOVES | Ngai Hing Latex Gloves Mfg. Co. | LYY | Class I | 1989-09-11 |
| K891509 | PATIENT EXAMINATION GLOVES (LATEX) | Delaware Industries, Inc. | LYY | Class I | 1989-09-11 |
| K892620 | PATIENT EXAMINATION GLOVES (LATEX) | Permark Sdn. Bhd. | LYY | Class I | 1989-09-11 |
| K894398 | STERIGAGE INTEGRATOR TEST PACK FOR ETHYLENE OXIDE | Pymah Corp. | FRC | Class II | 1989-09-11 |
| K893095 | STERILE PATIENT EXAMINATION GLOVES (LATEX) | Asia Way Trading, Inc. | LYY | Class I | 1989-09-11 |
| K892182 | PATIENT EXAM GLOVES (MFG. SHANGHAI - CHANGZHENG) | Grand Monde Trading Co., Inc. | LYY | Class I | 1989-09-11 |
| K893159 | GLOBE PATIENT EXAMINATION GLOVES | Lucky and Happy, Inc. | LYY | Class I | 1989-09-11 |
| K894025 | VINYL EXAMINATION GLOVES (NON-STERILE) | Good Glove Corp. | LYZ | Class I | 1989-09-11 |
| K893294 | POWDER FREE VINYL (PVC) EXAM GLOVES | King Handy Five Corp. | LYZ | Class I | 1989-09-11 |
| K894399 | STERIGAGE INTEGRATOR TEST PACK FOR STEAM STERILI. | Pymah Corp. | FRC | Class II | 1989-09-11 |
| K892684 | PATIENT EXAMINATION GLOVES (LATEX) | Baldur Systems Corp. | LYY | Class I | 1989-09-11 |
| K892623 | PATIENT EXAMINATION GLOVES (LATEX) | Globe Ent., Inc. | LYY | Class I | 1989-09-11 |
| K894927 | SURGI SQUEEZ | Ethox Corp. | KZD | Class I | 1989-09-11 |
| K893280 | PROFECT EXAMINATION GLOVES | Shanghai Latex Factory | LYY | Class I | 1989-09-11 |
| K893279 | LATEX EXAMINATION GLOVES | Safetytech Sdn. Bhd. | LYY | Class I | 1989-09-11 |
| K893965 | PROLONG INTRAVASCULAR CATHETER | Baxter Healthcare Corp | FOZ | Class II | 1989-09-08 |
| K894788 | DMI SERIES 90 EXAMINATION TABLE | M.D. Intl., Inc. | KMN | Class I | 1989-09-08 |
| K892191 | PATIENT EXAMINATION GLOVES (VINYL) | Hsing YI Plastics Processing Co, Ltd. | LYZ | Class I | 1989-09-08 |
| K893263 | LATEX EXAMINATION GLOVES | Regent Group Co., Ltd. | LYY | Class I | 1989-09-08 |
| K893050 | PATIENT EXAMINATION GLOVES | Paratex Product Co., Ltd. | LYY | Class I | 1989-09-08 |
| K892622 | PATIENT EXAMINATION GLOVES (LATEX) | Latexon Co., Ltd. | LYY | Class I | 1989-09-07 |
| K894170 | DEVON DISPOSABLE HEAD POSITIONER COVER | Devon Industries, Inc. | KME | Class I | 1989-09-07 |
| K893418 | MYOCARDIAL PROBE THERMOMETER CODE 64000 | Dlp, Inc. | FLL | Class II | 1989-09-05 |
| K894003 | PATIENT EXAMINATION GLOVES | Beekay Hygiene Products | LYY | Class I | 1989-09-05 |
| K894849 | SENTRY LATEX EXAMINATION GLOVES | Vijayshree Spinning Mills , Ltd. | LYY | Class I | 1989-09-05 |
| K893049 | LANDSCAPE PATIENT EXAMINATION GLOVES | Pacific Intl. Economic & Technical, Inc. U.S.A. | LYY | Class I | 1989-09-05 |
| K892081 | PATIENT EXAMINATION GLOVES (LATEX) | Tacare Products , Ltd. | LYY | Class I | 1989-09-05 |
| K892994 | NON-STERILE VINYL EXAMINATION GLOVES | Sian-Yu Industrial Co., Ltd. | LYZ | Class I | 1989-09-05 |
| K891265 | LATEXCO LATEX EXAMINATION GLOVES | Latex Products Co., Inc. | LYY | Class I | 1989-09-05 |
| K892080 | PATIENT EXAMINATION GLOVES (LATEX) | The Orient Connection | LYY | Class I | 1989-09-05 |
| K892020 | PATIENT EXAMINATION GLOVES (LATEX) | Asset Ent., Sdn Bhd | LYY | Class I | 1989-09-01 |
| K890115 | AMBI-DEX (LATEX EXAMINATION GLOVES) | Globe Safety Products, Inc. | LYY | Class I | 1989-09-01 |
| K891831 | PATIENT EXAMINATION GLOVES (LATEX) | Pai Hoi Ent., Ltd. | LYY | Class I | 1989-09-01 |
| K892084 | PATIENT EXAMINATION GLOVES (LATEX) | Mirano Sdn. Bhd. | LYY | Class I | 1989-09-01 |
| K892485 | PATIENT EXAMINATION GLOVES (LATEX) | Intl. Pacific Industrial Corp. (Usa), Inc. | LYY | Class I | 1989-09-01 |
| K891744 | SURGIMAX PATIENT EXAM GLOVES (LATEX) | Excel Rubber Products (M) Sdn. Bhd. | LYY | Class I | 1989-09-01 |
| K892181 | PATIENT EXAM GLOVES (MFG. SHANGHAI LATEX FACTORY) | Grand Monde Trading Co., Inc. | LYY | Class I | 1989-09-01 |
| K893595 | PATIENT EXAMINATION GLOVES | Arcofield , Ltd. | LYY | Class I | 1989-09-01 |
| K892083 | SHIH KUO LATEX EXAM GLOVE | Beverly Ent., Inc. | LYY | Class I | 1989-09-01 |
| K892079 | CHAMP-PAQ VINYL PATIENT EXAM GLOVES | Winmed Instruments Mfg. Corp. | LYZ | Class I | 1989-09-01 |
| K893591 | LATEX EXAMINATION GLOVES | Shanghai Medicines & Health Products Import & Expo | LYY | Class I | 1989-09-01 |
| K892072 | PATIENT EXAMINATION GLOVES (LATEX) | Gaw Rubber Products Sdn. Bhd. | LYY | Class I | 1989-09-01 |
| K890905 | DISPOSABLE NON STERILE LATEX EXAM GLOVES | Harvest Intl. of America, Inc. | LYY | Class I | 1989-08-31 |
| K891793 | MICROMED LATEX EXAMINATION GLOVES | Siamland, Inc. | LYY | Class I | 1989-08-31 |
| K894022 | PATIENT EXAMINATION GLOVES (LATEX) | Baxter Healthcare Corp | LYY | Class I | 1989-08-31 |
| K892973 | LATEX NON-STERILE PATIENT EXAMINATION GLOVES | Polikon Trading Co. | LYY | Class I | 1989-08-31 |
| K894023 | PATIENT EXAMINATION GLOVES (VINYL) | Baxter Healthcare Corp | LYZ | Class I | 1989-08-31 |
| K892963 | PATIENT EXAMINATION GLOVES | Mao Gang Industrial Co. | LYY | Class I | 1989-08-31 |
| K891965 | SOFCARE PATIENT EXAMINATION GLOVES (LATEX) | P. T. Tata Rubberindo Industries | LYY | Class I | 1989-08-31 |
| K891730 | PATIENT EXAMINATION GLOVES (LATEX) | Athena Mfg., Inc. | LYY | Class I | 1989-08-31 |
| K891724 | PATIENT EXAMINATION GLOVES (LATEX) | United Lion Rubber Industries Sdn. Bhd. | LYY | Class I | 1989-08-31 |
| K891731 | PATIENT EXAMINATION GLOVES (LATEX) | Southern Medical Products, Inc. | LYY | Class I | 1989-08-31 |
| K891323 | LI WAH LATEX EXAMINATION GLOVES | Li Wah-Hong Kong, Inc. | LYY | Class I | 1989-08-31 |
| K893450 | LATEX EXAMINATION GLOVES | Ken FA Latex Products Corp. | LYY | Class I | 1989-08-31 |
| K891504 | PATIENT EXAMINATION GLOVE (LATEX) | Lon Tai Chemical Industrial Co., Ltd. | LYY | Class I | 1989-08-30 |
| K893085 | PATIENT EXAMINATION GLOVES | Jiangsu Medicines & Health Products Import & Expor | LYY | Class I | 1989-08-30 |
| K894212 | PHYNE-TOUCH-STERILE | Medical Resources, Ltd. | LYY | Class I | 1989-08-29 |
| K892978 | TIGER PATIENT EXAM GLOVES | Daesung America Co., Inc. | LYY | Class I | 1989-08-29 |
| K893823 | HARCROS EXAMINATION GLOVES | H&C Rubber Products Sdn. Bhd. | LYY | Class I | 1989-08-29 |
| K894773 | LATEX PATIENT EXAMINATION GLOVES | Transrich Industries Sdn. Bhd. | LYY | Class I | 1989-08-29 |
| K894324 | LATEX EXAMINATION GLOVES | M/S Overseas Latex Pvt. , Ltd. | LYY | Class I | 1989-08-29 |
| K894125 | PATIENT EXAMINATION GLOVES | Yaw Chang Enterprises Co., Ltd. | LYY | Class I | 1989-08-29 |
| K892210 | MULTI-DRUG(TM) INFUSION SYSTEM | I-Flow Corp. | FRN | Class II | 1989-08-28 |
| K894041 | PUMP-JECT SYRINGE WITH LUER-LOCK | Ziehm International, Inc. | FRN | Class II | 1989-08-28 |
| K893809 | COUGH PILLOW | Custom Hospitals Products | KMO | Class I | 1989-08-28 |
| K892047 | PATIENT EXAMINATION GLOVES (LATEX) | Gainlite Co., Ltd. | LYY | Class I | 1989-08-28 |
| K894037 | IVAC(R) SPACE.SAVER(TM) VOLUMETRIC PUMP MODEL 599 | Y | FRN | Class II | 1989-08-28 |
| K892179 | DISPOSABLE LATEX EXAMINATION GLOVES | Rex Latex Products Co., Ltd. | LYY | Class I | 1989-08-25 |
| K892045 | LATEX EXAMINATION GLOVES, NON-STERILE | C.N. Technocrats | LYY | Class I | 1989-08-25 |
| K893909 | MODIFIED MATERIAL USED IN INFUSION T | Quinton, Inc. | FPA | Class II | 1989-08-25 |
| K892034 | PATIENT EXAMINATION GLOVES (LATEX) | Sistem Med-Pro (M) Sdn Bhd | LYY | Class I | 1989-08-25 |
| K891667 | EVERGOOD BRAND (PATIENT EXAM GLOVES-LATEX) | San HU Chemical Industry Co., Ltd. | LYY | Class I | 1989-08-25 |
| K892413 | PATIENT EXAMINATION GLOVES (LATEX) | Beijing Jian Xing Latex Products Co., Ltd. | LYY | Class I | 1989-08-25 |
| K892175 | CORRECT TOUCH EXAMINATION GLOVES (LATEX) | Ampri Rubberware Industries Sdn Bhd | LYY | Class I | 1989-08-25 |
| K893492 | LATEX EXAMINATION GLOVES | Modern Rubber Industrial Co., Ltd. | LYY | Class I | 1989-08-24 |
| K894197 | LATEX EXAMINATION GLOVES | Medicare Industries, Inc. | LYY | Class I | 1989-08-24 |
| K893346 | LATEX EXAMINATION GLOVES | Avt Rubber Products , Ltd. | LYY | Class I | 1989-08-24 |
| K892793 | PATIENT EXAMINATION GLOVES (VINYL) | Zest Mark Industrial Co., Ltd. | LYY | Class I | 1989-08-24 |
| K894569 | MEDPRIDE LATEX EXAMINATION GLOVES | Transcorp | LYY | Class I | 1989-08-24 |
| K894774 | LATEX PATIENT EXAMINATION GLOVES | American Rubber Industries | LYY | Class I | 1989-08-24 |
| K892164 | PATIENT EXAMINATION GLOVES (VINYL) | King Handy Five Corp. | LYZ | Class I | 1989-08-23 |
| K892174 | LATEX EXAMINATION GLOVES (WINTEX) | Windwell Agencies Sdn. Bhd. | LYY | Class I | 1989-08-23 |
| K892177 | PATIENT EXAMINATION GLOVES (LATEX) | Chem-Specialties Sdn Bhd | LYY | Class I | 1989-08-23 |
| K892171 | DISPOSABLE LATEX EXAMINATION GLOVES | Soh King Neng & Sons Sdn Bhd | LYY | Class I | 1989-08-23 |
| K892170 | PATIENT EXAMINATION GLOVES (LATEX) | Pattana Latex Co., Ltd. | LYY | Class I | 1989-08-23 |
| K892043 | PATIENT EXAMINATION GLOVE (LATEX) | Mwe Asia America Industries Sdn | LYY | Class I | 1989-08-23 |
| K892317 | VINYL EXAM GLOVES (MFG. TSE FONG) | Svenska Medita Ac. | LYZ | Class I | 1989-08-22 |
15,723 clearances in the General Hospital panel. Data: openFDA.