Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 12
- Latest Decision
- 1989-09-28
Clearances · page 116 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K895353 | OPSITE I.V. 3000 | Smith & Nephew United, Inc. | KGX | Class I | 1989-09-28 |
| K894111 | VARI-SET | Sonex Medical | LDR | Class II | 1989-09-28 |
| K894129 | BILIBLANKET PHOTOTHERAPY DEVICE | Ohmeda Medical | LBI | Class II | 1989-09-28 |
| K894193 | LATEX EXAMINATION GLOVES | Hasil Getah Gulungan Pertama | LYY | Class I | 1989-09-28 |
| K894372 | NIPRO NEEDLE HOLDER | Pharma-Plast USA, Inc. | FMI | Class II | 1989-09-28 |
| K894487 | IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262+ | Y | LDR | Class II | 1989-09-27 |
| K895109 | SECONDARY IV SET WITH PROTECTED NEEDLE | Kendall Mcgaw Laboratories, Inc. | FPA | Class II | 1989-09-27 |
| K893624 | PREEMICARE MODEL 2500 TRANSPORT WARMER | Preemicare Corp. | FPL | Class II | 1989-09-27 |
| K895258 | LATEX PATIENT EXAMINATION GLOVES | Perfect Treasure Development , Ltd. | LYY | Class I | 1989-09-27 |
| K892635 | PATIENT EXAMINATION GLOVES (LATEX) | P.T. Multi Latexindo | LYY | Class I | 1989-09-27 |
| K893336 | LATEX EXAMINATION GLOVES | Lai Sun Industrial Co. | LYY | Class I | 1989-09-26 |
| K894916 | COMFEEL TRANSPARENT DRESSING | Coloplast A/S | KGX | Class I | 1989-09-26 |
| K895558 | ORIENT, LATEX EXAMINATION GLOVES | Rosa Intl. | LYY | Class I | 1989-09-26 |
| K894616 | LATEX EXAMINATION GLOVES | World Wide EX Im, Inc. | LYY | Class I | 1989-09-26 |
| K894488 | DANTEX VINYL EXAMINATION GLOVES | Dan Co., Ltd. | LYZ | Class I | 1989-09-26 |
| K892972 | 'JOBSTAR' PATIENT EXAMINATION GLOVES | Kai Sik Towa Rubber Products Sdn | LYY | Class I | 1989-09-26 |
| K892760 | PATIENT EXAMINATION GLOVES (LATEX) | Saha Import & Export Co. | LYY | Class I | 1989-09-26 |
| K894454 | PATIENT EXAMINATION GLOVES, LATEX | Windwell Agencies Sdn. Bhd. | LYY | Class I | 1989-09-26 |
| K894758 | PATIENT LATEX EXAMINATION GLOVES | Agrimal Industries Sdn. Bhd. | LYY | Class I | 1989-09-26 |
| K894796 | LATEX PATIENT EXAMINATION GLOVE | Bh Limela Industries Sdn. Bhd. | LYY | Class I | 1989-09-26 |
| K891513 | VINYL EXAMINATION GLOVES | Mann Chi Trading Co., Ltd. | LYZ | Class I | 1989-09-26 |
| K894739 | SURE-TEC LATEX EXAMINATION GLOVES | All American Poly of Pennsylvania Corp. | LYY | Class I | 1989-09-26 |
| K892505 | PATIENT EXAMINATION GLOVES | Wango Intl., Inc. | LYZ | Class I | 1989-09-26 |
| K895536 | LATEX PATIENT EXAMINATION GLOVES | Perfect Latex Pvt. , Ltd. | LYY | Class I | 1989-09-26 |
| K893105 | SAFETY TOUCH VINYL EXAMINATION GLOVES | Fedin Brothers Co., Inc. | LYY | Class I | 1989-09-26 |
| K893749 | CN GLOVES | C.N. Technocrats | LYY | Class I | 1989-09-26 |
| K893017 | SWED MED STERILE VINYL EXAMINATION GLOVES | New England Glove Company | LYZ | Class I | 1989-09-26 |
| K893569 | QUICK CHANGE MONTGOMERY STRAP | Med-Dex Intl. | KGX | Class I | 1989-09-25 |
| K895376 | ACTIDERM (TM) DERMATOLOGICAL PATCH | Convatec, A Division of E.R. Squibb & Sons | KGX | Class I | 1989-09-25 |
| K893745 | THE INDEPENDENT CARE UNIT | The Water Carriage Co., Inc. | FNL | Class II | 1989-09-22 |
| K894296 | PREMISE SERIES BED | Batesville American Mfg. Co. | FNL | Class II | 1989-09-22 |
| K893000 | GLOBE PATIENT EXAMINATION GLOVES | Lucky and Happy, Inc. | LYY | Class I | 1989-09-21 |
| K892077 | PATIENT EXAMINATION GLOVE (LATEX) | Forchic Corp. of USA | LYY | Class I | 1989-09-21 |
| K894196 | PATIENT EXAMINATION GLOVES | Lanka Products, Inc. | LYY | Class I | 1989-09-21 |
| K893882 | LATEX EXAMINATION GLOVES | Sinochem (Usa), Inc. | LYY | Class I | 1989-09-21 |
| K892781 | ANTELOPE BRAND PATIENT EXAMINATION GLOVES | Liaoning-Usa Corp. | LYY | Class I | 1989-09-21 |
| K894386 | LATEX EXAMINATION GLOVES | Ningbo Yujiang Plastic & Rubber Co. , Ltd. | LYY | Class I | 1989-09-21 |
| K892556 | PATIENT EXAMINATION GLOVES (LATEX) | Fabella Industries Sdn Bhd | LYY | Class I | 1989-09-21 |
| K894375 | PATIENT EXAMINATION GLOVES | Pan-Century Rubber Products Sdn. Bhd. | LYY | Class I | 1989-09-21 |
| K894499 | ARMOR, LATEX EXAMINATION GLOVES | Prestige Manufacturing Snd Bhd | LYY | Class I | 1989-09-21 |
| K893271 | VINYL EXAM GLOVES | Consul Chemical Industry Corp. | LYZ | Class I | 1989-09-21 |
| K894080 | LATEX EXAMINATION GLOVES | Shanghai Intl. Corp. | LYY | Class I | 1989-09-21 |
| K894696 | LATEX PATIENT EXAMINATION GLOVES | Sun Holy Manufactory , Ltd. | LYY | Class I | 1989-09-21 |
| K891429 | PATIENT EXAMINATION GLOVES (LATEX) | Wei Ming Industry Co. , Ltd. | LYY | Class I | 1989-09-21 |
| K892921 | PATIENT EXAMINATION GLOVES | Millimax Corp. | LYY | Class I | 1989-09-21 |
| K894178 | PATIENT EXAM GLOVES (MFG: GLOVES INT'L LTD.) | Lanka Products, Inc. | LYY | Class I | 1989-09-21 |
| K894801 | 30-CS01, 30-CS02, 30-CS03 CONTROL SYRINGES | Advance Medical Designs, Inc. | FMF | Class II | 1989-09-19 |
| K891444 | PERRY* STERILE X-AM* GLOVES | Smith & Nephew Medical | LYY | Class I | 1989-09-19 |
| K891193 | MEDI-TRACE ACCU-NATE DEVICE | Graphic Controls Corp. | FPA | Class II | 1989-09-19 |
| K891234 | TERUFUSION THREE WAY STOPCOCK | Terumo Medical Corp. | FMG | Class II | 1989-09-19 |
| K893767 | DISPOSABLE LATEX EXAMINATION GLOVES | Masif Healthcare Products Sdn. Bhd. | LYY | Class I | 1989-09-19 |
| K892970 | PATIENT EXAMINATION GLOVES (LATEX) | Naturub Sdn. Bhd. | LYY | Class I | 1989-09-18 |
| K892466 | PATIENT EXAMINATION GLOVES (LATEX) | Zir Lih Industrial Co., Ltd. | LYY | Class I | 1989-09-18 |
| K893716 | VOLUMETRIC PUMP SOLUTION SET FOR FLO-GARD 8000 | Baxter Healthcare Corp | FPA | Class II | 1989-09-18 |
| K892041 | PATIENT EXAMINATION GLOVES (LATEX) | United Gloves Sdn. Bhd. | LYY | Class I | 1989-09-18 |
| K892968 | TUFFTEX PATIENT EXAM GLOVES | Thai Latex, Inc. | LYY | Class I | 1989-09-18 |
| K893182 | LATEX EXAMINATION GLOVES | Higlo Rubber Products Sdn. Bhd. | LYY | Class I | 1989-09-18 |
| K892610 | PATIENT EXAMINATION GLOVES (LATEX) | Pt. Indolex Karya Prakarsa | LYY | Class I | 1989-09-18 |
| K893449 | LATEX EXAMINATION GLOVES | Lon Tai Chemical Industrial Co., Ltd. | LYY | Class I | 1989-09-18 |
| K892992 | PATIENT EXAMINATION GLOVES | Cypress Ent. | LYY | Class I | 1989-09-15 |
| K893275 | LATEX EXAMINATION GLOVES | Pt Ika Muda Corpora | LYY | Class I | 1989-09-15 |
| K893929 | LATEX EXAMINATION GLOVES | Ever Growing Ent. Co., Ltd. | LYY | Class I | 1989-09-15 |
| K894007 | PATIENT EXAMINATION GLOVES | Pre Lotus Industrial Sdn. Bhd. | LYY | Class I | 1989-09-15 |
| K893020 | PATIENT EXAMINATION GLOVES | Dover Products, Inc. | LYY | Class I | 1989-09-15 |
| K893338 | VINYL EXAMINATION GLOVES | Taiwan an Lih Ent. Co. , Ltd. | LYZ | Class I | 1989-09-15 |
| K890803 | LATEX EXAMINATION GLOVES | A-Tek Medical Supply | LYY | Class I | 1989-09-15 |
| K892021 | SUNNY TEX (PATIENT EXAMINATION GLOVES) | P.T. Indotama Megah Indah Rubber | LYY | Class I | 1989-09-15 |
| K894480 | PATIENT EXAMINATION GLOVES | Pt. Intan Hevea Industry | LYY | Class I | 1989-09-15 |
| K892095 | PATIENT EXAMINATION GLOVES (LATEX) | Madafair , Ltd. | LYY | Class I | 1989-09-15 |
| K892486 | UNI-LAB PATIENT EXAMINATION GLOVES (LATEX) | Unicable | LYY | Class I | 1989-09-13 |
| K893607 | PATIENT EXAMINATION GLOVES | Wedana Rubber Products | LYY | Class I | 1989-09-13 |
| K893695 | PATIENT EXAM GLOVES(MFG: SHANGHAI HUA LING LAT FAC | Shanghai Industrial Investment Co. , Ltd. | LYY | Class I | 1989-09-13 |
| K893302 | LATEX EXAMINATION GLOVES | Gromax Rubber Industry Co., Ltd. | LYY | Class I | 1989-09-13 |
| K893719 | MEDI + FORM EXAM (MFG: GLOVE SEAL SDN BHD) | World Impex Corp. | LYY | Class I | 1989-09-13 |
| K893115 | LATEX EXAMINATION GLOVES | Naturub Sdn. Bhd. | LYY | Class I | 1989-09-13 |
| K893304 | LATEX EXAMINATION GLOVES | Lakewood Ent., Ltd. | LYY | Class I | 1989-09-13 |
| K893292 | LATEX EXAMINATION GLOVES | Mahagewang Sdn Bhd | LYY | Class I | 1989-09-13 |
| K893293 | LATEX EXAMINATION GLOVES | Toptech Industry Corp. | LYY | Class I | 1989-09-13 |
| K894079 | LATEX EXAMINATION GLOVES | Target USA, Inc. | LYY | Class I | 1989-09-13 |
| K894787 | MEL-PAK GENERAL DRUG DELIVERY SYSTEM KIT | New York Blood Center, Inc. | FPA | Class II | 1989-09-13 |
| K893618 | PATIENT EXAMINATION GLOVES | Tenma Co. , Ltd. | LYY | Class I | 1989-09-13 |
| K891326 | PATIENT EXAMINATION GLOVES (LATEX) | Medigloves , Ltd. | LYY | Class I | 1989-09-13 |
| K893303 | LATEX EXAMINATION GLOVES | Marble King Corp. | LYY | Class I | 1989-09-13 |
| K892774 | PATIENT EXAMINATION GLOVES | Liaoning-Usa Corp. | LYY | Class I | 1989-09-13 |
| K893154 | LATEX EXAMINATION GLOVES | Magna Intl., Inc. | LYY | Class I | 1989-09-13 |
| K893158 | TOPCLEAN PATIENT EXAMINATION GLOVES | Pt. Herlin Dharma Persada | LYY | Class I | 1989-09-13 |
| K891856 | SUPER GLOVES PATIENT EXAM GLOVES (LATEX) | World Wide Trade Network, Inc. | LYY | Class I | 1989-09-13 |
| K892290 | PATIENT EXAMINATION GLOVES (NATURAL FEELINGS) | B.Y.K. Trading, Inc. | LYY | Class I | 1989-09-13 |
| K893306 | LATEX EXAMINATION GLOVES | Acefit Intl., Inc. | LYY | Class I | 1989-09-13 |
| K892297 | PATIENT EXAM GLOVES (MFG. EATON RUBBER GLOVES CO.) | B.Y.K. Trading, Inc. | LYY | Class I | 1989-09-13 |
| K892107 | PATIENT EXAMINATION GLOVES (LATEX) | Success Development (Usa) Co., Inc. | LYY | Class I | 1989-09-13 |
| K892771 | PATIENT EXAMINATION GLOVES (POLY) | P.A. Research Corp. | LZA | Class I | 1989-09-13 |
| K891723 | PATIENT EXAMINATION GLOVES (LATEX) | Khoo Chemical Industrial Sdn Bhd | LYY | Class I | 1989-09-13 |
| K892754 | PATIENT EXAMINATION GLOVES (VINYL) | Baxter Healthcare Corp | LYZ | Class I | 1989-09-13 |
| K891669 | PATIENT EXAMINATION GLOVE (LATEX) | Beauty Thai Rubber Chemical Co., Ltd. | LYY | Class I | 1989-09-13 |
| K893593 | PATIENT EXAMINATION GLOVES | Strong Will Sdn Bhd | LYY | Class I | 1989-09-13 |
| K892953 | PATIENT EXAMINATION GLOVES | Masju Sdn. Bhd. | LYY | Class I | 1989-09-13 |
| K891336 | PATIENT EXAMINATION GLOVES (VINYL) | Kaohsiung Brothers Products Corp. | LYZ | Class I | 1989-09-13 |
| K885319 | NON-STERILE EXAM GLOVES | Straitscom | LYY | Class I | 1989-09-13 |
| K893155 | LATEX EXAMINATION GLOVES | Success Development (Usa) Co., Inc. | LYY | Class I | 1989-09-13 |
15,723 clearances in the General Hospital panel. Data: openFDA.