meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
26
Latest Decision
2000-01-28

Clearances · page 70 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K994248 SENSI-PRO, DISPOSABLE PRE-POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVES Shinemound Enterprise, Inc. LYZ Class I 2000-01-28
K994064 BLUE NITRILE EXAMINATION GLOVES - POWDER FREE Glove Source, Inc. LZA Class I 2000-01-28
K991023 STERITITE PERFORATED BOTTOM RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02 - POLYPROPYLENE NON-WOVEN DISPOSABL Case Medical, Inc. FRG Class II 2000-01-27
K993848 MILLENNIUM HUBER PLUS SAFETY INFUSION SET Millennium Medical Distribution, Inc. FPA Class II 2000-01-27
K994216 PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM Sims Deltec, Inc. LJT Class II 2000-01-27
K994013 POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) Glovco (M) Sdn. Bhd. LYY Class I 2000-01-20
K993864 COLORED AND FLAVORED POWDER FREE LATEX EXAMINATION GLOVES Supermax Sdn Bhd LYY Class I 2000-01-20
K992675 PATIENT NITRILE EXAMINATION GLOVES (POWDERED) Wear Safe Malaysia Sdn. Bhd. LZA Class I 2000-01-20
K993797 EC-7701 FLUID WARMING CABINET Enthermics Medical Systems, Inc. LDQ 2000-01-20
K994258 SENSI-PRO DISPOSABLE POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVES Shinemound Enterprise, Inc. LYZ Class I 2000-01-20
K993865 GREEN PEPPERMINT FLAVORED POWDERED LATEX EXAMINATION GLOVES Supermax Sdn Bhd LYY Class I 2000-01-20
K993614 FAS ENDOLUMINAL BRUSH Fas Medical , Ltd. LJS Class II 2000-01-18
K993849 TEH LOONG VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVE Longbest (Xiamen) Balls Co., Ltd. LYZ Class I 2000-01-18
K993847 TEH LOONG, VINYL, POWDERED, PATIENT EXAMINATION GLOVES Longbest (Xiamen) Balls Co., Ltd. LYZ Class I 2000-01-18
K991936 3.0 ML RESERVOIR, MODEL 103/193 Medtronic Minimed FRN Class II 2000-01-18
K984551 INFRARED EAR THERMOMETER, MODEL KI-8120 K-Jump Health Co., Ltd. FLL Class II 2000-01-14
K992729 NIPRO LUER ADAPTOR Nipro Medical Corp. FMI Class II 2000-01-13
K992258 HOT SHOT FLUID WARMER IV FLUIDS Infra-Med Technologies, Inc. LDQ 2000-01-12
K993880 SHANGHAI GLOVMAX ENTERPRISE CO, LTD., POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Shanghai Glovmax Enterprise Co.,Ltd LYZ Class I 2000-01-12
K993859 SHANGHAI GLOVMAX ENTERPRISE CO., LTD. PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES Shanghai Glovmax Enterprise Co.,Ltd LYZ Class I 2000-01-12
K993567 INNOVATIVE GLOVES LATEX EXAMINATION GLOVES POWDERFREE WITH PROTEIN LABELING CLAIM [50 MICROGRAMS OR LESS] Innovative Gloves Co;, Ltd. LYY Class I 2000-01-12
K993793 GUTHRIE PRIME PRE-POWDERED PATIENT LATEX EXAMINATION GLOVE Guthrie Medicare Products (Melaka) Sdn Bhd LYY Class I 2000-01-12
K994043 CORRECT TOUCH LATEX POWDERED EXAMINATION GLOVES Biopro (M) Sdn Bhd LYY Class I 2000-01-11
K993664 SYNTHETIC VINYL MEDICAL EXAMINATION POWDERED GLOVES Top Glove Sdn. Bhd. LYZ Class I 2000-01-11
K992744 MIDMARK M4*9 EASYCLAVE STEAM STERILIZER Midmark Corp. FLE Class II 2000-01-10
K992767 BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR Albert Browne , Ltd. JOJ Class II 2000-01-10
K993039 VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700) Bausch & Lomb, Inc. MRH Class II 2000-01-07
K994253 VACLOK SYRINGE Merit Medical Systems, Inc. FMF Class II 2000-01-05
K993407 OHMEDA MEDICAL OMNIBED Ohmeda Medical FMZ Class II 2000-01-05
K993463 INTRAVASCULAR ADMINISTRATION SET Custom Assemblies, Inc. FPA Class II 2000-01-04
K994111 CELSITE, MODELS ST401L, ST405L B. Braun/Mcgaw LJT Class II 2000-01-03
K994186 DISETRONIC D-TRON INSULIN INFUSION PUMP Disetronic Medical Systems LZG Class II 1999-12-30
K994197 DISENTRONIC PENFINE INJECTION PEN NEEDLE Disetronic Medical Systems FMI Class II 1999-12-29
K993621 HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MIC Pamitex Industries Sdn Bhd LYY Class I 1999-12-29
K993529 POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) Biografik (Malaysia) Sdn Bhd LYY Class I 1999-12-29
K994039 ABBOTT GEMSTAR I.V. INFUSION PUMP-7 THERAPY CONFIGURATION, ABBOTT GEMSTAR I.V. INFUSION PUMP-6 THERAPY CONFIGURATION, AB Abbott Laboratories FRN Class II 1999-12-22
K993386 LATEX EXAMINATION POWDERED GLOVES Great Glove Sdn Bhd LYY Class I 1999-12-20
K993605 PEPPER GREEN MINT POWDERED LATEX EXAMINATION GLOVES Top Glove Sdn. Bhd. LYY Class I 1999-12-20
K993452 GREEN POWDERED LATEX EXAMINATION GLOVES Top Glove Sdn. Bhd. LYY Class I 1999-12-20
K994036 PRE-POWDERED VINYL EXAM GLOVE, NON STERILE Shanghai Champion Plastic Products Co., Ltd. LYZ Class I 1999-12-20
K993835 PARAPOST SYSTEM STERILIZABLE ORGANIZER Coltene/Whaledent, Inc. FRG Class II 1999-12-16
K992626 SURE-WAY REUSABLE SHARPS CONTAINER Sure-Way Systems, Inc. FMI Class II 1999-12-16
K992676 PATIENT LATEX EXAMINATION POWDER-FREE POLYMER COATED GLOVES Wear Safe Malaysia Sdn. Bhd. LYY Class I 1999-12-16
K992681 PATIENT LATEX EXAMINATION GLOVE POWDERED & POWDER FREE, STERILE Wear Safe Malaysia Sdn. Bhd. LYY Class I 1999-12-16
K993764 MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCH Medipack Medical Packaging Mfg. Co. KCT Class II 1999-12-16
K993379 PALL SUPOR AEF FILTER Pall Corp. FPB Class II 1999-12-16
K993680 SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE Top Glove Sdn. Bhd. LYZ Class I 1999-12-13
K990308 ROCAP HEPARIN IV FLUSH SYRINGE, 100U/ML Rocap Div. of Sabratek Corp. FOZ Class II 1999-12-10
K990390 HEPARIN IV FLUSH SYRINGE, 10 U/ML \ Rocap Div. of Sabratek Corp. FOZ Class II 1999-12-10
K992995 AROMATIC AND FLAVORED TONGUE DEPRESSOR Aga Plastic Ind. Com. Ltda. FMA Class I 1999-12-09
K993907 VIRIDIA INFORMATION CENTER SOFTWARE FOR M3154A OPT C22 Agilent Technologies, Inc. MHD Class II 1999-12-06
K993255 BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE Coltene/Whaledent, Inc. FRG Class II 1999-12-06
K993454 POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL CLAIM - 50 MICROGRAMS OR LESS) Sri Johani Sdn. Bhd. LYY Class I 1999-12-03
K991575 PRIMUS STEAM STERILIZERS Primus Sterilizer Co., Inc. FLE Class II 1999-12-03
K993860 CATHETER INNOVATIONS IMPLANTABLE PORT Catheter Innovations, Inc. LJT Class II 1999-12-03
K993752 GLOVCO, POWDER-FREE CHLORINATED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) Glovco (M) Sdn. Bhd. LYY Class I 1999-12-03
K993271 QUALITY LATEX POWDERED LATEX MEDICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 170 MICROGRAM OR LESS Quality Latex Corp. Sdn Bhd LYY Class I 1999-12-02
K993457 POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) [50 MICROGRAMS OR LESS] Sri Johani Sdn. Bhd. LYY Class I 1999-12-02
K993820 POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN LABELING CLAIM 50 MICROGRAM OR LESS Felda Rubber Corp. LYY Class I 1999-12-02
K993500 POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL OF 50 MCROGRAM OR LESS) Besglove Medicare Sdn. Bhd. LYY Class I 1999-12-02
K993127 MULTI-COMFORT NITRILE EXAMINATION GLOVES, (POWDER FREE) Glovesworld Industries Sdn. Bhd. LZA Class I 1999-12-02
K992862 SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES Shijiazhuang Great Vision Plastic Products Co., LT LYZ Class I 1999-11-29
K993502 POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM 50 MICROGRAMS OR LESS) Besglove Medicare Sdn. Bhd. LYY Class I 1999-11-24
K993495 POWDERED LATEX EXAMINATION GLOVES(PROTEIN LABEL CLAIM 150 MICROGRAMS OR LESS) Besglove Medicare Sdn. Bhd. LYY Class I 1999-11-24
K993725 GREEN CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS Hartalega Sdn Bhd LYY Class I 1999-11-23
K993722 BLUE CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS. Hartalega Sdn Bhd LYY Class I 1999-11-23
K993313 COMFIT POWDER FREE BLUE NITRILE EXAMINATION GLOVE, STERILE Wrp Asia Pacific Sdn. Bhd. LZA Class I 1999-11-23
K992341 CIDEX OPA SOLUTION TEST STRIP Serim Research Corp. JOJ Class II 1999-11-23
K993666 DISETRONIC PEN P100 Disetronic Medical Systems FMF Class II 1999-11-22
K993183 POWDER FREE GLOVES (POLYMER COATED) Pan-Century Rubber Products Sdn. Bhd. LYY Class I 1999-11-19
K993419 OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE; POLYMER COATED WITH PROTEIN CLAIM (50 MICROGRAMS OR LESS) Omnigrace , Ltd. LYY Class I 1999-11-19
K993049 DISPOSABLE PVC POWDERED SYNTHETIC EXAMINATION GLOVES Shanghai Antares Industries, Inc. LYZ Class I 1999-11-19
K993347 NIL, NITRILE EXAMINATION GLOVE - POWDERED Sri Anusham Rubber Industries Pvt., Ltd. LZA Class I 1999-11-19
K993311 COMFIT POWDER FREE NITRILE EXAMINATION GLOVE, STERILE Wrp Asia Pacific Sdn. Bhd. LZA Class I 1999-11-19
K993479 OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (100 MICROGRAMS OR LESS) Omnigrace (Thailand) , Ltd. LYY Class I 1999-11-19
K993348 NIL, NITRILE EXAMINATION GLOVE - POWDER FREE Sri Anusham Rubber Industries Pvt., Ltd. LZA Class I 1999-11-19
K992697 PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM Sims Deltec, Inc. LJT Class II 1999-11-18
K993134 CASHMERE NON-STERILE BLUE POWDERED NITRILE EXAMINATION GLOVESBLUE AND GREEN) Seal Polymer Industries Bhd. LZA Class I 1999-11-17
K993120 MODIFIED BLOOD RECIPIENT SET Baxter Healthcare Corp BRZ Class II 1999-11-17
K993133 CASHMERE NON-STERILE POWDERED NITRILE EXAMINATION GLOVES BLUE AND GREEN Seal Polymer Industries Bhd. LZA Class I 1999-11-17
K993326 NON-STERILE POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (70 MICROGRAMS OR LESS PER Seal Polymer Industries Bhd. LYY Class I 1999-11-17
K992678 PATIENT NITRILE EXAMINATION GLOVES POWDER FREE CHLORINATED Wear Safe Malaysia Sdn. Bhd. LZA Class I 1999-11-17
K993012 MINIMED COM-STATION, HARDWARE-7301; SOFTWARE-7311 Medtronic Minimed LZG Class II 1999-11-15
K993385 AUTOJET 2 (NON-FIXED NEEDLE TYPE) Owen Mumford USA, Inc. KZH Class II 1999-11-10
K993458 POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) Sri Johani Sdn. Bhd. LYY Class I 1999-11-10
K993050 OMNI GRACE NITRILE, GREEN, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED Omnigrace , Ltd. LZA Class I 1999-11-09
K993712 BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM Ohmeda Medical FMZ Class II 1999-11-09
K992702 EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM Allergy Direct FMW Class I 1999-11-08
K993221 INNOVATIVE GLOVES, LATEX EXAMINATION GLOVES, PREPOWDERED Innovative Gloves Co;, Ltd. LYY Class I 1999-11-05
K992924 QTEXX, NON-CHLORINATED, POWDER FREE NITRILE EXAMINATION GLOVES, POLYMER-COATED Latexx Partners Bhd. LZA Class I 1999-11-05
K992999 DAISY PROTECTED SCALP VEIN SET Diasol, Inc. FPA Class II 1999-11-05
K993187 SHELLY PROTECTED AV FISTULA NEEDLE Diasol, Inc. FPA Class II 1999-11-05
K993222 INNOVATIVE GLOVES, LATEX EXAMINATION GLOVES POWDERFREE Innovative Gloves Co;, Ltd. LYY Class I 1999-11-05
K993325 INNOVATIVE GLOVES, NITRILE BUTADIENE RUBBER POWDER-FREE Innovative Gloves Co;, Ltd. LZA Class I 1999-11-05
K992797 SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES Shijiazhuang Hongxiang Plastics Products Co., Ltd. LYZ Class I 1999-11-05
K993247 NITRILE POWDER FREE PATIENT EXAMINATION GLOVES Jda Intl., Inc. LZA Class I 1999-11-05
K993147 DECAP The Kipp Group FPA Class II 1999-11-02
K993387 IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K Baxter Healthcare Corp FRN Class II 1999-11-01
K990677 ABSOGEL CHEMOTHERAPHY GLOVES Ampri Rubberware Industries Sdn Bhd LZC Class I 1999-11-01
K993287 POWDER FREE (SILICON COATED) LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM Pan-Century Rubber Products Sdn. Bhd. LYY Class I 1999-10-29

15,723 clearances in the General Hospital panel. Data: openFDA.