meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
31
Latest Decision
1998-04-14

Clearances · page 77 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K980605 LOW PROTEIN LATEX PATIENT EXAMINATION GLOVES (POWDER-FREE) Pt. Sarana Indoprotex LYY Class I 1998-04-14
K980589 AR SAFE NITRILE EXAMINATION GLOVES Alliance Rubber Products Sdn. Bhd. LZA Class I 1998-04-14
K980179 SHARPS PLUS 5 GALLON SHARPS CONTAINER Rotonics Mfg., Inc. FMI Class II 1998-04-13
K980472 KHT SOFT NEEDLE, ACUPUNCTURE NEEDLE American Institute of Koryo Hand Therapy MQX Class II 1998-04-09
K980451 BIODERM CALCIUM ALGINATE DRESSING Bioderm, Inc. KMF Class I 1998-04-09
K980471 KHT GUAM NEEDLE, ACUPUNCTURE NEEDLE American Institute of Koryo Hand Therapy MQX Class II 1998-04-09
K980768 VACUETTE HOLDEX Greiner Meditech, Inc. FMI Class II 1998-04-09
K980470 KHT SOFT SOOJI NEEDLE, HAND ACUPUNCTURE NEEDLE American Institute of Koryo Hand Therapy MQX Class II 1998-04-06
K980336 IV STANDS Clinton Industries, Inc. FOX Class I 1998-04-06
K980939 SAFETY POWDERED BLUE LATEX EXAMINATION GLOVES Besglove Medicare Sdn. Bhd. LYY Class I 1998-04-03
K980469 KHT SOOJI NEEDLE, HAND ACUPUNCTURE NEEDLE American Institute of Koryo Hand Therapy MQX Class II 1998-04-03
K980803 STERILE POWDER-FREE LATEX EXAMINATION GLOVES Kenwell International , Ltd. LYY Class I 1998-04-03
K980940 SAFETY POWDERFREE BLUE LATEX EXAMINTION GLOVES Besglove Medicare Sdn. Bhd. LYY Class I 1998-04-03
K980941 SAFETY POWDERFREE BLUE LATEX EXAMINATION GLOVES (POLYMER COATED) Besglove Medicare Sdn. Bhd. LYY Class I 1998-04-03
K980755 B-D E ML PEN Bd Becton Dickinson Vacutainer Systems Preanalytic FMF Class II 1998-04-02
K974660 LATEX EXAMINATION GLOVE Ideal Quality Sdn., Bhd. LYY Class I 1998-04-02
K974662 POWDER-FREE LATEX EXAMINATION GLOVE Ideal Quality Sdn., Bhd. LYY Class I 1998-04-02
K980807 NITRILE EXAMNATION GLOVES- POWDERFREE (SMALL, MEDIUM AND LARGE) Pt. Eka Wira Asia LZA Class I 1998-04-02
K980181 TERUMO DISPOSABLE HYPODERMC SYRINGE Terumo Medical Corp. FMF Class II 1998-04-02
K980729 NITRILE EXAMINATION GLOVES- PRE-POWDERED (SMALL, MEDIUM & LARGE) Pt. Eka Wira Asia LZA Class I 1998-04-02
K980611 POWDERED LATEX EXAMINATION GLOVES Servicom Services Sdn Bhd LYY Class I 1998-04-02
K980796 TERUMO ALLERGY SYRINGE Terumo Corp. FMF Class II 1998-04-02
K972300 CROSS-CHECKS P Steritec Products Mfg Co, Inc. JOJ Class II 1998-03-25
K980802 NITRILE EXAM GLOVE, POWDER-FREE, BLUE Tucker & Associates LZA Class I 1998-03-25
K980090 ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM) Luther Medical Products, Inc. LJS Class II 1998-03-24
K980089 3600 PRESURE INFUSOR, SIGMACON 3600, LAPRO FLOW 3000 Valley West, Inc. FRN Class II 1998-03-24
K980062 MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DEVICE Davis & Geck, Inc. FMI Class II 1998-03-20
K974778 ABBOTT GEMSTAR IV INFUSION PUMP Abbott Laboratories FRN Class II 1998-03-17
K971612 OSMO/PCA PILLOW WOUND DRESSING Procyte Corp. KMF Class I 1998-03-16
K980677 NITRILE EXAM GLOVE, POWDER FREE Ningbo Yujiang Plastic & Rubber Co. , Ltd. LZA Class I 1998-03-16
K980167 POWDERFREE LATEX EXAMINATION GLOVES Besglove Medicare Sdn. Bhd. LYY Class I 1998-03-13
K974870 LATEX EXAMINATION GLOVE POWDER FREE Smart Glove Corp. Sdn Bhd LYY Class I 1998-03-13
K980618 LOVYTEX SDN BHD POWDER-FREE LATEX EXAMINATION GLOVES Lovytex Sdn Bhd LYY Class I 1998-03-13
K980285 POWDERFREE BLUE NITRILE EXAMINATION GLOVES Besglove Medicare Sdn. Bhd. LZA Class I 1998-03-13
K974557 SMARTTEX Smart Glove Corp. Sdn Bhd LYY Class I 1998-03-13
K980572 POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (GREEN) Hartalega Sdn Bhd LYY Class I 1998-03-13
K980215 LATEX EXAMINATION GLOVES P.T. Wantong Industry LYY Class I 1998-03-13
K980194 POWDERFREE LATEX EXAMINATION GLOVES Besglove Medicare Sdn. Bhd. LYY Class I 1998-03-13
K980003 M500-100 SHARPS CONTAINER Imagination Medical, Inc. FMI Class II 1998-03-13
K980421 OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED Omnigrace (Thailand) , Ltd. LZA Class I 1998-03-13
K974907 NITRILE PRE-POWDERED EXAMINATION GLOVES Smart Glove Corp. Sdn Bhd LZA Class I 1998-03-13
K980275 POWDERFREE BLUE NITRILE EXAMINATION GLOVES (POLYMER COATED) Besglove Medicare Sdn. Bhd. LZA Class I 1998-03-13
K980280 POWDERED NITRILE EXAMINATION GLOVES (BLUE COLOUR) Besglove Medicare Sdn. Bhd. LZA Class I 1998-03-13
K980511 NITRILE EXAMINATION GLOVES - POWDER FREE Influx Pacific Sdn. Bhd. LZA Class I 1998-03-13
K973664 LATEX EXAM GLOVE, POWDER-FREE W/PROTEIN & HYPOALLERGENIC LABELING Evergrade Healthcare Products Sdn Bhd LYY Class I 1998-03-13
K980419 OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE Omnigrace (Thailand) , Ltd. LZA Class I 1998-03-13
K980071 SUPERGLOVES LOW PROTEIN POWDER FREE LATEX EXAMINATION GLOVES Supermax Latex Products Sdn. Bhd. LYY Class I 1998-03-13
K980318 POWDER-FREE LATEX EXAMINATION GLOVES (BLUE) Hartalega Sdn Bhd LYY Class I 1998-03-11
K980127 6 INCH MINI-BONE EXTENSION SET WITH LUER LOCK, NES01S, 6 INCH MIN-BONE EXTENSION SET WITH LUER SLIP, NES02S, 6 INCH STAT Catheter Innovations, Inc. FPA Class II 1998-03-11
K973748 TEMPO AND TEMP H20 Smith LGZ Class II 1998-03-10
K980086 HEAT STACK Medical Solutions, Inc. LGZ Class II 1998-03-10
K973916 NP MEDICAL CAPLESS LUER ACTIVATED VALVE Np Medical, Inc. FPA Class II 1998-03-09
K980382 NON-WOVEN COMPRESS Convatec, A Division of E.R. Squibb & Sons KMF Class I 1998-03-09
K974759 HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE Hydrox Laboratories JOL Class II 1998-03-09
K980092 SMITH & NEPHEW DYONICS INTELIJET REUSABLE CANNULAS Smith & Nephew, Inc. FRN Class II 1998-03-09
K974758 HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE Hydrox Laboratories JOL Class II 1998-03-09
K980082 J-TIP NEEDLESS INJECTOR National Medical Products, Inc. KZE Class II 1998-03-04
K962903 PRESTIGE MEDICAL SERIES 2100 CLINICAL AUTOCLAVE Prestige Medical Corp. FLE Class II 1998-03-03
K980381 PHASEAL, CLOSED SYSTEM FORHANDLING OF PARENTERAL DRUGS, ADDITIONAL ADMINISTRATION DEVICES. C80 INFUSION ADAPTER, A10 PRO Carmel Pharma Ab. LHI Class II 1998-03-03
K974475 THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012 Biocontrol Technology, Inc. LJT Class II 1998-03-02
K980093 DISPOSABLE SYNTHETIC PATIENT EXMINATION GLOVES, POWDER FREE Universal Gloves Corp. LYZ Class I 1998-03-02
K972877 ULTRASAFE INJECTION SYSTEM MODEL C200 INJECTOR WITH NEEDLE GUARD Safety Syringes, Inc. FMF Class II 1998-02-26
K974764 INTROSYTE CATHETER Becton Dickinson Infusion Therapy Systems, Inc. FOZ Class II 1998-02-26
K972900 ULTRASAFE MODEL T200 INJECTOR Safety Syringes, Inc. FMF Class II 1998-02-26
K974710 NITRILE EXAM GLOVE, POWDER-FREE/WHITE AND BLUE Sinochem Ningbo Latex Gloves Factory LZA Class I 1998-02-25
K974253 CPD COMMANDER Scieran Technologies, Inc. MRH Class II 1998-02-25
K974180 STERI-TAMP Pharmacy, Inc. KPE Class II 1998-02-24
K980490 SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPS Sage Products, Inc. MMK Class II 1998-02-24
K974782 LOW PROTEIN POWDER FREE LATEX EXAMINATION GLOVES Mexpo Intl., Inc. LYY Class I 1998-02-24
K973169 PRESSURE GUARD SITE SELECT (A) Span-America Medical Systems, Inc. FNM Class II 1998-02-20
K974823 NONWOVEN DRESSING Convatec, A Division of E.R. Squibb & Sons KMF Class I 1998-02-20
K972158 GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES Princeton Regulatory Assoc. MEB Class II 1998-02-20
K974074 INFUSION DYNAMICS POWER INFUSER Infusion Dynamics, Inc. KZD Class I 1998-02-17
K980369 T.B.Q. RTU STERIS Corporation LRJ Class I 1998-02-17
K974349 OHMEDA-OHIO CARE PLUS INCUBATOR Ohmeda Medical FMZ Class II 1998-02-12
K974829 NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET) Kawasumi Laboratories Co., Ltd. LJT Class II 1998-02-12
K980069 VANISHPOINT SYRINGE Retractable Technologies, Inc. MEG Class II 1998-02-12
K973827 KIMBERLY-CLARK SELF-SEAL POUCH FOR LOW TEMPERATURE STERILIZATION Kimberly-Clark Corp. KCT Class II 1998-02-11
K974832 POWDERFREE LATEX EXAMINATION GLOVES Servicom Services Sdn Bhd LYY Class I 1998-02-11
K974661 0.2 U BACTERIAL FILTER Sims Deltec, Inc. FPB Class II 1998-02-11
K974543 L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER Luther Medical Products, Inc. FOZ Class II 1998-02-10
K973225 CASTLE SERIES 200 STEAM STERILIZER (POWERCLAVE) Getinge/Castle, Inc. FLE Class II 1998-02-10
K974397 STERILE SALINE FOR CATHETER CARE Baxter Healthcare Corp JOL Class II 1998-02-10
K980038 POWDERFREE GREEN LATEX EXAMINATION GLOVES Sri Johani Sdn. Bhd. LYY Class I 1998-02-09
K980039 POWDERED GREEN LATEX EXAMINATION GLOVES Sri Johani Sdn. Bhd. LYY Class I 1998-02-09
K980037 POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED) Sri Johani Sdn. Bhd. LYY Class I 1998-02-09
K974853 LATEX (POWDER FREE) LOW PROTEIN P.T. Healthcare Glovindo LYY Class I 1998-02-09
K980150 POWDER-FREE NITRILE EXAMINATION GLOVES Masju Sdn. Bhd. LZA Class I 1998-02-09
K974205 KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBON Convatec, A Division of E.R. Squibb & Sons KMF Class I 1998-02-06
K973734 STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION Welcon, Inc. JOL Class II 1998-02-05
K974616 SINGER ACUPUNCTURE NEEDLES Lorac, Inc. MQX Class II 1998-02-05
K974195 FLEXIBLE TIP DIGITAL THERMOMETER K-Jump Health Co., Ltd. FLL Class II 1998-02-04
K974163 MINIMED SOF-SET ULTIMATE QR INFUSION SET MODELS 315 AND 316 Medtronic Minimed FPA Class II 1998-02-02
K974777 VINYL EXAMINATION GLOVES POWDER FREE Sun Flower Gloves Co., Ltd. LYZ Class I 1998-01-30
K974886 POWDERED GREEN NITRILE EXAMINATION GLOVES Sri Johani Sdn. Bhd. LZA Class I 1998-01-30
K974887 POWDERFREE GREEN NITRILE EXAMINATION GLOVES Sri Johani Sdn. Bhd. LZA Class I 1998-01-29
K973981 SAFEPASS STERILIZATION POUCH Adroit Medical Systems, Inc. KCT Class II 1998-01-29
K980149 POWDERED NITRILE EXAMINATION GLOVES Masju Sdn. Bhd. LZA Class I 1998-01-29
K973792 EASYSAFE RETRACTING NEEDLE SYRINGE Saf-T-Med, Inc. MEG Class II 1998-01-29
K971369 BROWNE MVI STEAM INDICATOR Albert Browne , Ltd. JOJ Class II 1998-01-29

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