meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
22
Latest Decision
1999-02-19

Clearances · page 74 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K990117 DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE Shanghai Palomar Mountain Industries, Inc. LYZ Class I 1999-02-19
K984381 BURETROL SOLUTION SETS Baxter Healthcare Corp FPA Class II 1999-02-19
K990285 LAGLOVE BRAND LATEX EXAMINATION GLOVES (LOW PROTEIN) La Glove (M) Sdn. Bhd. LYY Class I 1999-02-18
K990270 LAGLOVE BRAND LATEX EXAMINATION GLOVE (POWDER FREE) La Glove (M) Sdn. Bhd. LYY Class I 1999-02-18
K984615 POWDERED NITRILE EXAMINATION GLOVES Shiva Medicare , Ltd. LZA Class I 1999-02-17
K983368 CARE BAND ANTIBACTERIAL BANDAGES Aso Corp. KGX Class I 1999-02-17
K990259 DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM Disetronic Medical Systems FRN Class II 1999-02-12
K984309 NBR 4 MILS, NITRILE EXAMINATION GLOVE NON-STERILE POWDERED Sumirubber Industries (Kedah) Sdn. Bhd. LZA Class I 1999-02-12
K983887 UP-GRADE AND UP-GRADE PRO Medisim, Ltd. FLL Class II 1999-02-12
K990083 CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER Sims Deltec, Inc. FPA Class II 1999-02-12
K990300 SUPRASHIELD EXPRESS STERILIZATION WRAP Allegiance Healthcare Corp. FRG Class II 1999-02-10
K984461 PRE-POWDER VINYL PATIENT EXAMINATION GLOVES Shanghai Huamao Gloves Co., Ltd. LYZ Class I 1999-02-09
K983411 COLORVEES IV SET 20 DROPS/ML 105, 60 DROPS/ML 105, VENTED 20 DROPS 105, VENTED 60 DROPS 105 Valnet Medical Corp. FPA Class II 1999-02-09
K984638 PARAGON BOLUS ACCESSORY SET I-Flow Corp. FPA Class II 1999-02-09
K984610 POWDER FREE NITRILE EXAMINATION GLOVES Shiva Medicare , Ltd. LZA Class I 1999-02-09
K982151 STERITITE PROCESS INDICATOR ACCESSORIES Case Medical, Inc. JOJ Class II 1999-02-09
K983430 LITE-TOUCH SYRINGE Medicore, Inc. FMF Class II 1999-02-09
K984146 PARAGON INFUSION I-Flow Corp. FPA Class II 1999-02-09
K984460 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Shanghai Huamao Gloves Co., Ltd. LYZ Class I 1999-02-09
K984063 PARAGON BASAL/BOLUS ADMINISTRATION SET I-Flow Corp. FPA Class II 1999-02-09
K984311 NBR4 MILS NITRILE POWDER FREE EXAMINATION GLOVES NON-STERILE Sumirubber Industries (Kedah) Sdn. Bhd. LZA Class I 1999-02-09
K984125 POWDERED LATEX EXAMINATION GLOVES, NON-STERILE Kilang Barangan Getah Dioh LYY Class I 1999-02-09
K984561 SUBCUTANEOUS INFUSION SETS, MSR MODEL A & B Msr, Inc. FPA Class II 1999-02-04
K984613 BROWNE SPORICIDIN PHENOL INDICATOR FOR SPORICIDIN STERILIZING AND DISINFECTING SOLUTION Albert Browne , Ltd. JOJ Class II 1999-02-04
K983614 UNISEAL POWDER-FREE LATEX EXAMINATION GLOVES (BLUE & GREEN COLORED) American Healthcare Products (M) Sdn Bhd LYY Class I 1999-02-04
K984616 BROWNE SPORICIDIN GLUTARALDEHYDE INDICATOR FOR SPORICIDIN STERILIZING AND DISINFECTING SOLUTION Albert Browne , Ltd. JOJ Class II 1999-02-04
K972719 CLARICEL STERILIZATION POUCHES AND STERILIZATION REELS Medicel, S.A. DE C.V. KCT Class II 1999-02-04
K983005 PERFUSOR COMPACT B.Braun Medical, Inc. FRN Class II 1999-02-04
K984055 CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS Sims Deltec, Inc. FOZ Class II 1999-01-29
K973227 ASKINA HYDROCOLLOID/THIN B.Braun Medical, Inc. KMF Class I 1999-01-28
K972616 ONCOLOGY PLUS POWDER FREE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING) Wembley Rubber Products (M) Sdn Bhd LYY Class I 1999-01-27
K983145 TEXTURED POWDER-FREE LATEX EXAM GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) Shen Wei (Usa), Inc. LYY Class I 1999-01-26
K972615 CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING) Wembley Rubber Products (M) Sdn Bhd LYY Class I 1999-01-26
K982178 VAGABOND SOFT RESTRAINT SYSTEM Emergent Innovations, Ltd. FMQ Class I 1999-01-26
K984605 POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON COLORED) Perusahaan Getah Asas Sdn. Bhd. LZA Class I 1999-01-25
K984127 POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE Kilang Barangan Getah Dioh LYY Class I 1999-01-25
K983998 POWDER FREE LATEX EXAMINATION GLOVES Sri Anusham Rubber Industries Pvt., Ltd. LYY Class I 1999-01-21
K983828 NITRIKLEEN- NITRILE EXAMINATION GLOVE POWDER FREE Sinetimed Latex Sdn Bhd LZA Class I 1999-01-21
K982114 LOPRO SILICONISED LOW PROTEIN POWDERFREE LATEX EXAMINATION GLOVES M/S Midland Latex Products , Ltd. LYY Class I 1999-01-21
K983926 MPS GRAVITY FLOW CONTROL SET Critical Device Corp. FPA Class II 1999-01-20
K983217 ROWE DUAL-CHECK VALVE Cook, Inc. FPA Class II 1999-01-20
K984147 LOVYTEX SND BHD POWDER-FREE POLYMER COATED LATEX EXAMINATION GLOVES Lovytex Sdn Bhd LYY Class I 1999-01-20
K982332 STERIS TEN SIXTEEN STEAM STERILIZER STERIS Corporation FLE Class II 1999-01-20
K983570 GLOVE SEAL D'PRO LATEX EXAMINATION GLOVE Glove Seal Sdn Bhd LYY Class I 1999-01-14
K982805 INTROCAN SAFETY IV CATHETER B.Braun Medical, Inc. FOZ Class II 1999-01-14
K983827 MAXIKLEEN-LATEX EXAMINATION GLOVE POWDER FREE Sinetimed Latex Sdn Bhd LYY Class I 1999-01-14
K983223 DENTAL STERLIZATION TRAY/CASSETTE Brasseler USA I, L.P. FRG Class II 1999-01-14
K984553 TALKING DIGITAL THERMOMETER, MODEL KV-171 K-Jump Health Co., Ltd. FLL Class II 1999-01-14
K984094 VINYL EXAMINATION GLOVES, PREPOWDERED USP Trans Ancient Products Co., Ltd. LYZ Class I 1999-01-14
K984485 MICROSTAT 2 Chemlink Laboratories, LLC LRJ Class I 1999-01-13
K983544 VYGON DOUBLE LUMEN PICC-CATHETERS (4FR. AND 5FR.) Vygon Corp. LJS Class II 1999-01-13
K984040 BLOSSOM POWDERED LATEX EXAMINATION GLOVES Mexpo Intl., Inc. LYY Class I 1999-01-13
K982159 ABBOTT PLUM A+ INFUSION PUMP Abbott Laboratories FRN Class II 1999-01-12
K981625 STERRAD 50 STERILIZER Advanced Sterilization Products MLR Class II 1999-01-11
K983994 UNIFINE Owen Mumford USA, Inc. FMF Class II 1999-01-08
K984356 NITRILE PATIENT EXAMINATION GLOVE, BLUE OR GREEN COLORED (PREPOWDERED USP) Perusahaan Getah Asas Sdn. Bhd. LZA Class I 1999-01-08
K983679 STATIM 5000 CASSETTE AUTOCLAVE Scican FLE Class II 1999-01-04
K983519 COMFEEL SEASORB DRESSING Coloplast Corp. KMF Class I 1998-12-30
K974332 VARIABLE PRESSURE SYRINGE PUMP Alaris Medical Systems, Inc. FRN Class II 1998-12-29
K982897 POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) Pt. Maja Agung Latexindo LYY Class I 1998-12-23
K984020 POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS) Kossan Latex Industries(M)Sdn Bhd LYY Class I 1998-12-23
K982832 PROGUARD, RR-1, RR-2 Emerson & Co. Srl LZC Class I 1998-12-23
K984019 POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAMS OR LESS) Kossan Latex Industries(M)Sdn Bhd LYY Class I 1998-12-23
K983974 OWEN MUMFORD 3ML AUTOPEN Owen Mumford USA, Inc. FMF Class II 1998-12-21
K983568 OSTAR D'PRO LATEX POWDERED EXAMINATION GLOVES, PROTEIN CLAIM OF 100 MCGM OR/LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER Contract Latex Dippers Sdn Bhd LYY Class I 1998-12-21
K982901 LATEX PATIENT EXAMINATION GLOVE, CAT. NO. 1000M POWDERED Vitalcare Group, Inc. LYY Class I 1998-12-21
K980117 NUVO BARRIER FILM Biomedical Development Co. KMF Class I 1998-12-18
K984177 MODIFICATION TO SKVEKPATCH Marine Polymer Technologies, Inc. KMF Class I 1998-12-18
K970736 BRAUN PREFILLED SYRINGE B.Braun Medical, Inc. FOZ Class II 1998-12-16
K983073 I.V. EXTENSION SET OR I.V. ADMINISTRATION SET Integra Biotechnical, LLC FPA Class II 1998-12-16
K983454 PAIN CARE 2000 Breg, Inc. MEB Class II 1998-12-16
K981942 LATEX POWDER FREE EXAMINATION GLOVES Maika Rubber Products Sdn Bhd LYY Class I 1998-12-14
K982612 ESP7 VENOUS IMAGE Ironmaster, Inc. KZA Class I 1998-12-14
K983730 OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, BLUE Omnigrace , Ltd. LZA Class I 1998-12-11
K983729 POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE Perusahaan Getah Asas Sdn. Bhd. LZA Class I 1998-12-11
K983210 ALGISITE M Smith & Nephew, Inc. KMF Class I 1998-12-10
K983412 MEDCOMP H-CATH TRIPLE LUMEN CENTRAL VENOUS ACCESS CATHETER, MODEL SIC 12-3T Medical Components, Inc. LJS Class II 1998-12-10
K983833 ACTICOAT COMPOSITE WOUND DRESSING, ACTICOAT COMPOSITE WOUND DRESSING-ADHESIVE Westaim Biomedical, Inc. KMF Class I 1998-12-10
K980378 MELODIE INFUSION PUMP Compagnie DE Developpement Aguettant FRN Class II 1998-12-09
K982140 CLINICAL ELECTRONIC THERMOMETER Valeo Corp. FLL Class II 1998-12-08
K983725 OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED, BLUE Omnigrace , Ltd. LZA Class I 1998-12-07
K983723 CHLORINATED, POLYMER-COATED, POWDER-FREE LATEX EXAMINATION GLOVE Kossan Latex Industries(M)Sdn Bhd LYY Class I 1998-12-07
K983146 ARSOFT Alliance Rubber Products Sdn. Bhd. LZA Class I 1998-12-07
K981917 POWDER FREE (CHLORINATED) LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) Oon Corp. Resources LYY Class I 1998-12-07
K981054 BROWNE GA INDICATOR FOR CIDEX PRODUCTS Albert Browne , Ltd. JOJ Class II 1998-12-07
K983721 POLYMER-COATED, POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE Kossan Latex Industries(M)Sdn Bhd LYY Class I 1998-12-07
K983645 SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES Shijiazhuang Great Eagle Plastic Products Co., Ltd. LYZ Class I 1998-12-04
K983947 AMERSE 2 STERIS Corporation LRJ Class I 1998-12-04
K981816 CUE AMBULATORY VOLUMETRIC INFUSION PUMP Becton Dickinson Curlin, LLC FRN Class II 1998-12-04
K983825 NITRILE LATEX POWDER FREE EXAMINATION GLOVE Top Glove Sdn. Bhd. LZA Class I 1998-12-04
K982885 PRE-POWDERED NON-STERILE SYNTHETIC EXAMINATION GLOVE Shanghai Poseidon Plastic Products Co., Ltd. LYZ Class I 1998-12-04
K983816 NITRILE LATEX POWDERED EXAMINATION GLOVE Top Glove Sdn. Bhd. LZA Class I 1998-12-04
K982218 NITRILE POWDER-FREE UNISEAL GLOVES American Healthcare Products (M) Sdn Bhd LZA Class I 1998-11-30
K983750 DEROYAL INDUSTRIES, INC TRACECART SHARPS COLLECTION CONTAINER Deroyal Industries, Inc. FMI Class II 1998-11-30
K981979 UNISEAL GLOVES LOW PROTEIN POWDERED American Healthcare Products (M) Sdn Bhd LYY Class I 1998-11-30
K982170 FLUIDSENSE FLUID DELIVERY SYSTEM Fluidsense Corp. FRN Class II 1998-11-30
K983532 POWDER FREE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVE, COLORED Shanghai Antares Industries, Inc. LYZ Class I 1998-11-30
K982716 OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE, WITH PROTEIN CLAIM Omnigrace (Thailand) , Ltd. LYY Class I 1998-11-30
K983869 DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH Caltech Industries, Inc. LRJ Class I 1998-11-30
K983531 POWDERED NITRILE MEDICAL EXAMINATION GLOVE, COLORED Shanghai Antares Industries, Inc. LYZ Class I 1998-11-30

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