Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 22
- Latest Decision
- 1989-07-14
Clearances · page 121 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K891174 | PATIENT EXAMINATION GLOVES (LATEX) | Howard Associates, Inc. | LYY | Class I | 1989-07-14 |
| K892155 | PATIENT EXAM GLOVES (MFG. HUBEI TIANMEN LATEX) | Sinochem (Usa), Inc. | LYY | Class I | 1989-07-14 |
| K892270 | PATIENT EXAMINATION GLOVES (LATEX) | Global Latex Products Sdn Bhd | LYY | Class I | 1989-07-14 |
| K892790 | PATIENT EXAMINATION GLOVES (LATEX) | Dann Overseas, Inc. | LYY | Class I | 1989-07-14 |
| K890891 | LATEX EXAMINATION GLOVES (MFG. NINGBO MEDICAL) | Interpro Intl., Inc. | LYY | Class I | 1989-07-14 |
| K891857 | PATIENT EXAMINATION GLOVES (LATEX) | General Merchandise Co. | LYY | Class I | 1989-07-14 |
| K892273 | PATIENT EXAMINATION GLOVES (LATEX) | Rouge Ent., Inc. | LYY | Class I | 1989-07-14 |
| K891937 | PATIENT EXAMINATION GLOVES (LATEX) | Kosel Industries Sdn Bhd | LYY | Class I | 1989-07-14 |
| K892916 | PATIENT EXAMINATION GLOVES (LATEX) | China National Medicines & Health Prod. I/E Corp. | LYY | Class I | 1989-07-14 |
| K892680 | PATIENT EXAMINATION GLOVES (NATURAL RUBBER) | Texla Industries Sdn. Bhd. | LYY | Class I | 1989-07-14 |
| K892955 | PATIENT EXAMINATION GLOVES (LATEX) | Awb Ent., Inc. | LYY | Class I | 1989-07-05 |
| K890931 | PATIENT EXAMINATION GLOVE | Phutex Products Co., Ltd. | LYY | Class I | 1989-06-23 |
| K892266 | PATIENT EXAMINATION GLOVES (LATEX) | Jenn Jiag Ent. Co., Ltd. C/O Rosyn Products, Inc. | LYY | Class I | 1989-06-23 |
| K890360 | GREER DERMAPIK SYSTEM | Greer Laboratories, Inc. | SCL | Class II | 1989-06-23 |
| K891164 | SAMUELS - MICRO -SCLER CATHETER | Polyval, Inc. | FPA | Class II | 1989-06-23 |
| K892289 | PATIENT EXAMINATION GLOVES (LATEX) | Ansell, Inc. | LYY | Class I | 1989-06-23 |
| K892566 | PATIENT EXAMINATION GLOVES (LATEX) | Foodhandler, Inc. | LYY | Class I | 1989-06-23 |
| K893391 | MI-328, MI-316, MI-388 DIGITAL THERMOMETER | Nam Tai Electronic & Electrical Products, Ltd. | FLL | Class II | 1989-06-23 |
| K891087 | TERUMO SURFLO(R) I.V. CATHETER | Terumo Medical Corp. | FOZ | Class II | 1989-06-23 |
| K891063 | SURFLO(R) WINGED INFUSION SET | Terumo Medical Corp. | FPA | Class II | 1989-06-23 |
| K891146 | TERUMO SURFLO(R) INJECTION PLUG | Terumo Medical Corp. | FPA | Class II | 1989-06-23 |
| K893460 | A-PORT IMPLANT VASCULAR ACCESS SYSTEM .6MM/2.29MM | Therex Corp. | LJT | Class II | 1989-06-23 |
| K891855 | WINFIELD LATEX EXAMINATION GLOVES | Winfield Co., Inc. | LYY | Class I | 1989-06-22 |
| K893018 | HPI NON STERILE EXAM GLOVES | Tillotson Corp. | LYY | Class I | 1989-06-22 |
| K892017 | PURAFLEX PATIENT EXAMINATION GLOVES | Medsi, Inc. | LYY | Class I | 1989-06-22 |
| K892976 | SINGLE USE VINYL EXAM GLOVES - COLOR CODED | Phoenix Medical Technology, Inc. | LYZ | Class I | 1989-06-22 |
| K891418 | LATEX EXAMINATION GLOVES, STYLE 510 LX | C & K Mfg. & Sales Co. | LYY | Class I | 1989-06-22 |
| K893135 | GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER | Premium Plastics, Inc. | JOL | Class II | 1989-06-22 |
| K891835 | BUD BRAND PATIENT EXAMINATION GLOVES (VINYL) | Associated Ent., Inc. | LYZ | Class I | 1989-06-22 |
| K892152 | PATIENT EXAM GLOVES (MFG. NINGBO MEDICAL LATEX) | Sinochem (Usa), Inc. | LYY | Class I | 1989-06-22 |
| K891952 | TRU-TOUCH VINYL EXAM GLOVES (CANADA) | Bd Becton Dickinson Vacutainer Systems Preanalytic | LYZ | Class I | 1989-06-22 |
| K884978 | PHARMA-PLAST INSULIN INFUSION SET | Pharma-Plast USA, Inc. | LZG | Class II | 1989-06-21 |
| K892915 | PLEUR-EVAC A-8002--ADULT/PEDIATRIC DUAL COLLECTION | Deknatel, Inc. | KDQ | Class II | 1989-06-21 |
| K890930 | PATIENT EXAMINATION GLOVES | Thaima Products Co., Ltd. | LYY | Class I | 1989-06-21 |
| K892480 | PATIENT EXAMINATION GLOVES | Foodhandler, Inc. | LYY | Class I | 1989-06-21 |
| K892506 | PATIENT EXAMINATION GLOVES (LATEX) | Universal Latex Products Co., Ltd. | LYY | Class I | 1989-06-21 |
| K892309 | PATIENT EXAMINATION GLOVES (LATEX) | Min an Chemical Industrial Co., Ltd. | LYY | Class I | 1989-06-21 |
| K891457 | DR. VOLKNER'S LAMELLAR TURNING BED(TM) | James Consolidated, Inc. | FNM | Class II | 1989-06-20 |
| K890926 | SURECUT BMB BONE MARROW BIOPSY/ASPIRATION NEEDLE | Meadox Surgimed, Inc. | FMI | Class II | 1989-06-20 |
| K891702 | PATIENT EXAMINATION GLOVES (LATEX) | Thai Nam Rubber Gloves Co., Ltd. | LYY | Class I | 1989-06-19 |
| K892975 | LOW POWDER SINGLE USE LATEX EXAM GLOVES | Phoenix Medical Technology, Inc. | LYY | Class I | 1989-06-19 |
| K892471 | PATIENT EXAMINATION GLOVES (LATEX) | Tabri Gloves Sdn. Bhd. | LYY | Class I | 1989-06-19 |
| K891644 | SAMBORD LATEX PATIENT EXAMINATION GLOVES | Polymint Industrial Co. , Ltd. | LYY | Class I | 1989-06-19 |
| K893268 | LATEX EXAMINATION GLOVES | Regulus Intl. Corp. | LYY | Class I | 1989-06-19 |
| K893015 | LATEX EXAMINATION GLOVES | Universal Gloves Private , Ltd. | LYY | Class I | 1989-06-19 |
| K891958 | THE ROYAL GLOVES (PATIENT EXAM GLOVES) | Taizhu Latex Glove Factory , Ltd. | LYY | Class I | 1989-06-19 |
| K892247 | PATIENT EXAMIAINATION GLOVES (LATEX) | Jiann FA Rubber Factory Co., Ltd. | LYY | Class I | 1989-06-19 |
| K893107 | CHAMP-PAQ LATEX PATIENT EXAMINATION GLOVES | Winmed Instruments Mfg. Corp. | LYY | Class I | 1989-06-19 |
| K893179 | WARDEN LATEX EXAMINATION GLOVES | Kuo Jun Ent. Co., Ltd. | LYY | Class I | 1989-06-19 |
| K891374 | PATIENT EXAMINATION GLOVES (LATEX) | M.R.G. Industries Sdn. Bhd. | LYY | Class I | 1989-06-19 |
| K892414 | QUALITEX LATEX EXAMINATION GLOVES | Agri-Bag Corp. | LYY | Class I | 1989-06-19 |
| K890728 | STERILE IRRIGATION TRAYS | Cypress Medical Products, Ltd. | KYZ | Class I | 1989-06-16 |
| K890476 | ADEL - MODEL 986 INFANT WARMER | Adel Medical , Ltd. | FMZ | Class II | 1989-06-16 |
| K884759 | SHOWER STRETCHER W/WHEELS | Linido, Inc. | FPO | Class II | 1989-06-15 |
| K890845 | PREMISE SERIES BED | Batesville American Mfg. Co. | FNL | Class II | 1989-06-15 |
| K892052 | SARNS MEDICAL CART | 3M Company | LDQ | 1989-06-15 | |
| K892877 | CRADLE, HOSPITAL BED CLOTHING | Warsaw Orthopedic, Inc. | FNJ | Class I | 1989-06-15 |
| K892923 | LATEX PATIENT EXAMINATION GLOVES | Gigantic International Corp. | LYY | Class I | 1989-06-14 |
| K892625 | PATIENT EXAMINATION GLOVES (LATEX) | Hand Care, Inc., Ltd. | LYY | Class I | 1989-06-14 |
| K893166 | LATEX EXAMINATION GLOVES | Gulfwin Holding Sdn. Bhd. | LYY | Class I | 1989-06-14 |
| K892965 | LATEX EXAM GLOVES (MFG. BROADLAND RUBBER INDUST.) | Dmp, Inc. | LYY | Class I | 1989-06-14 |
| K892624 | PATIENT EXAMINATION GLOVES (LATEX) | Sanital Co., Ltd. | LYY | Class I | 1989-06-14 |
| K892961 | PATIENT EXAMINATION GLOVES | Viratect, Inc. | LYY | Class I | 1989-06-14 |
| K892768 | PATIENT EXAMINATION GLOVES (POLY) | Promedica Products, Inc. | LZA | Class I | 1989-06-14 |
| K892945 | PATIENT EXAMINATION GLOVES | R.J.M. Precaution Products, Inc. | LYY | Class I | 1989-06-14 |
| K893098 | VINYL EXAM GLOVES (MFG. TOPLAS INDUSTRIAL CO.) | Jason Co. | LYZ | Class I | 1989-06-14 |
| K893047 | JASONTEX LATEX EXAMINATION GLOVES | Jasontex Co., Ltd. | LYY | Class I | 1989-06-14 |
| K893266 | LATEX EXAMINATION GLOVES | Yi-Gang Machinery & Engineering Co., Ltd. | LYY | Class I | 1989-06-14 |
| K891611 | MODELS 6526,6527,6528 PERCU. TRANS. ANGIO. CATH. | Medtronic Versaflex, Inc. | LJT | Class II | 1989-06-12 |
| K891880 | PATIENT EXAMINATION GLOVES (LATEX) | Jextrag Schaffhausen AG | LYY | Class I | 1989-06-09 |
| K893056 | PATIENT EXAMINATION GLOVES | Hope Rubber Industrial Corp. | LYY | Class I | 1989-06-09 |
| K891583 | IVAC VARIABLE PRESSURE VOLUMETRIC PUMP, 570 SERIES | Y | FRN | Class II | 1989-06-09 |
| K893149 | PLYMOUTH & LAWANA EXAM GLOVES | Healthgard Medical Products Ltd. Partnership | LYY | Class I | 1989-06-09 |
| K892288 | PATIENT EXAMINATION GLOVES (LATEX) | Ansell, Inc. | LYY | Class I | 1989-06-09 |
| K892741 | PATIENT EXAMINATION GLOVES (LATEX) | Dmacs Intl. Corp. | LYY | Class I | 1989-06-09 |
| K890489 | EXTENSION SET W/FLOW REGULATOR | Baxter Healthcare Corp | FPA | Class II | 1989-06-08 |
| K892919 | LATEX DISPOSABLE EXAMINATION GLOVES | Union Industrial Co., Ltd. | LYY | Class I | 1989-06-07 |
| K885173 | MIX CONTAINER W/ATTACHED TRANSFER SET | Medical Support Systems | KPE | Class II | 1989-06-07 |
| K892099 | PATIENT EXAMINATION GLOVES (LATEX) | Tung Kuang Rubber Factory Co. , Ltd. | LYY | Class I | 1989-06-07 |
| K890844 | MICROSEPT 60/20 | Arbor Technologies, Inc. | CAK | Class II | 1989-06-07 |
| K892752 | PATIENT EXAM GLOVES (MFG. WOOD TING INDUSTRY) | Foodhandler, Inc. | LYY | Class I | 1989-06-06 |
| K891843 | RANK PATIENT EXAM GLOVES (MFG. INTER-CONTINENTAL) | Worldwide Medical | LYY | Class I | 1989-06-06 |
| K892985 | PATIENT EXAMINATION GLOVES | Eac Rubber Industries (M) Sdn. Bhd. | LYY | Class I | 1989-06-06 |
| K892150 | PATIENT EXAMINATION GLOVES (LATEX) | Dmp, Inc. | LYY | Class I | 1989-06-06 |
| K891825 | PATIENT EXAMINATION GLOVES (LATEX) | J & T Medical Products Co., Ltd. | LYY | Class I | 1989-06-06 |
| K892701 | PATIENT EXAMINATION GLOVES (LATEX) | Nature'S Farm Products (Thailand) Co., Ltd. | LYY | Class I | 1989-06-06 |
| K891832 | PATIENT EXAMINATION GLOVES (LATEX) | Integrasia Sdn Bhd | LYY | Class I | 1989-06-06 |
| K891658 | REGENT BIOGEL D(TM) NON-STERILE DENTAL GLOVES | Regent Hospital Products | LYY | Class I | 1989-06-06 |
| K891834 | NIL PATIENT EXAMINATION GLOVES (LATEX) | Glatex Sdn Bhd | LYY | Class I | 1989-06-06 |
| K891660 | PROLIFE PATIENT EXAMINATION GLOVES (LATEX) | B J L Glove (M) Sdn. Bhd. | LYY | Class I | 1989-06-06 |
| K891879 | SUMMA PROTECH: DELTA SERIES PATIENT EXAM GLOVES | Summa Intl. | LYY | Class I | 1989-06-06 |
| K891872 | PATIENT EXAMINATION GLOVES (LATEX) | Orient Intl. Trading, Inc. | LYY | Class I | 1989-06-06 |
| K893148 | ALMATEX EXAM GLOVES (MFG. CONCEPT RUBBER) | Healthgard Medical Products Ltd. Partnership | LYY | Class I | 1989-06-06 |
| K891421 | PATIENT EXAMINATION GLOVES (LATEX) | Charone, Inc. | LYY | Class I | 1989-06-06 |
| K891830 | PATIENT EXAMINATION GLOVES (LATEX) | Perindustrian Masmuar Sdn Bhd | LYY | Class I | 1989-06-06 |
| K891878 | PATIENT EXAMINATION GLOVES (LATEX) | Pacific Delta Medical Supply | LYY | Class I | 1989-06-02 |
| K891244 | PATIENT EXAMINATION GLOVES (LATEX) | Ganda Yakin Sdn Bhd | LYY | Class I | 1989-06-02 |
| K892621 | PATIENT EXAMINATION GLOVES (LATEX) | Fadr Intl., Inc. | LYY | Class I | 1989-06-02 |
| K892574 | VINYL PATIENT EXAMINATION GLOVES | Encore Products, Inc. | LYZ | Class I | 1989-06-02 |
| K892298 | PATIENT EXAM GLOVES (MFG. HEART CREDIT INDUSTRIAL) | B.Y.K. Trading, Inc. | LYY | Class I | 1989-06-02 |
15,723 clearances in the General Hospital panel. Data: openFDA.