meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
24
Latest Decision
1999-05-20

Clearances · page 73 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K990690 POLYMER COATED POWDERFREE LATEX EXAMINTATION GLOVES Top Glove Sdn. Bhd. LYY Class I 1999-05-20
K990936 THE VAULT Stik Stoppers, Inc. FMI Class II 1999-05-18
K990955 MODIFICATION OF:BIODERM FOAM WOUND DRESSING Bioderm, Inc. KMF Class I 1999-05-18
K990841 NUGARD NITRIL NITRILE EXAMINATION GLOVE Terang Nusa Sdn Bhd LZA Class I 1999-05-17
K990879 PRE POWDERED LATEX EXAMINATION GLOVES Apl Products Sdn. Bhd. LYY Class I 1999-05-17
K991627 WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600 Respironics, Inc. LBI Class II 1999-05-17
K984229 LATEX EXAMINATION GLOVES (POWDERED) Sama Kejuruteraan Sdn.Bhd. LYY Class I 1999-05-17
K990840 NUGARD NITRIL POWDERFREE NITRILE EXAMINATION GLOVE Terang Nusa Sdn Bhd LZA Class I 1999-05-17
K991404 PLATYPUS AV FISTULA NEEDLE PROTECTOR (AVFNP) Itl Corporation Pty, Ltd. FMI Class II 1999-05-14
K990693 FLEXNEEDLE PLUS Act Medical, Inc. FPA Class II 1999-05-14
K991501 ACCLAIM INFUSION PUMP Abbott Laboratories FRN Class II 1999-05-13
K990696 OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE,WHITE Omnigrace (Thailand) , Ltd. LZA Class I 1999-05-13
K991363 30 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR CONTINUOUS, PCA PUMP, PAIN MANAGEMENT, PCEA PUMP, EPIDU Sorenson Medical, Inc. FRN Class II 1999-05-13
K990698 OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED PURPLE Omnigrace (Thailand) , Ltd. LZA Class I 1999-05-13
K990729 FAMOUS PHYSICIANS BRAND DISPOSABLE ACUPUNCTURE NEEDLES Acc Intl. MQX Class II 1999-05-13
K990447 1000 PRESSURE INFUSION SIGMACON 1000 Valley West, Inc. FRN Class II 1999-05-12
K984496 ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN Atrium Medical Corp. KDQ Class II 1999-05-05
K984189 ARGON MULTI-LUMEN CENTRAL VENOUS CATHETER Maxxim Medical FOZ Class II 1999-05-05
K991085 BROTHERS, VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVES Long First (Xiamen) Co., Ltd. LYZ Class I 1999-05-05
K990701 OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, PURPLE Omnigrace (Thailand) , Ltd. LZA Class I 1999-05-05
K990575 TA CHIA POWDERED NON-STERILE NITRILE PATIENT EXAMINATION GLOVES Ta Chia Rubber Ind. Corp. LZA Class I 1999-05-04
K990577 TA CHIA POWDER FREE NON-STERILE NITRILE PATIENT EXAMINATION GLOVES Ta Chia Rubber Ind. Corp. LZA Class I 1999-05-04
K990702 OMNI GRACE LATEX EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED WITH PROTEIN CLAIM Omnigrace (Thailand) , Ltd. LYY Class I 1999-05-04
K990946 BROTHERS VINYL, POWDERED, PATIENT EXAMINATION GLOVES Long First (Xiamen) Co., Ltd. LYZ Class I 1999-05-04
K990328 DBC, DONG BANG ACUPUNCTURE NEEDLES Morning Star, Dong Bang Acupuncture U.S.A., Inc. MQX Class II 1999-05-04
K990695 OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED WHITE Omnigrace (Thailand) , Ltd. LZA Class I 1999-05-04
K984249 SKINSENSE NITRILE POWDER-FREE SYNTHETIC MEDICAL EXAMINATION GLOVE London International Group, Inc. LZA Class I 1999-05-04
K990686 POWDER FREE LATEX EXAMINATION GLOVES Tower Rubber Industries Sdn. Bhd. LYY Class I 1999-05-04
K991043 LATEX EXAMINATION GLOVES POWDERED, LOW PROTEIN Glovco (M) Sdn. Bhd. LYY Class I 1999-05-04
K990901 POWDER FREE LATEX EXAMINATION GLOVES Apl Products Sdn. Bhd. LYY Class I 1999-05-04
K990812 POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTA Ampri Rubberware Industries Sdn Bhd LYY Class I 1999-05-04
K990906 FERRIS POLYMEM POLYWIC STERILE CAVITY WOUND FILLER Ferris Mfg. Corp. KMF Class I 1999-04-29
K990468 LATEX EXAMINATION GLOVE W/ LOW PROTEIN LABELING Top Glove Sdn. Bhd. LYY Class I 1999-04-27
K990526 KLEENHANDS POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM Ssn Gloves (M) Sdn Bhd LYY Class I 1999-04-23
K990427 ARSOFT NITRILE EXAMINATION GLOVES, NON-STERILE POWDER FREE Alliance Rubber Products Sdn. Bhd. LZA Class I 1999-04-23
K990425 SIDEKICK INFUSION KIT I-Flow Corp. FRN Class II 1999-04-23
K990485 NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, GREEN COLOR Alliance Rubber Products Sdn. Bhd. LZA Class I 1999-04-23
K991044 DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVE, NON STERILE (PROTEIN CONTENT LABELING) Wrp Specialty Products Sdn. Bhd. LYY Class I 1999-04-23
K990527 KLEENHANDS POWDERED LATEX EXAMINATION GLOVES Ssn Gloves (M) Sdn Bhd LYY Class I 1999-04-23
K991294 MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM Medi-Ject Corp. KZE Class II 1999-04-23
K990486 NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, BLUE COLOR. Alliance Rubber Products Sdn. Bhd. LZA Class I 1999-04-23
K983451 CHALLENGE TEST PACK North American Science Assoc., Inc. JOJ Class II 1999-04-23
K990312 AVIA PAIN MEDICATION DELIVERY SYSTEM Amtec Medical MEA Class II 1999-04-22
K990371 DIABETIC NEEDLE DISPOSAL, MODEL # PMSM - 950 Post Medical, Inc. FMI Class II 1999-04-21
K984589 PHOTOTHERAPY LAMP Medela, Inc. LBI Class II 1999-04-20
K990189 MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER Midmark Corp. FLE Class II 1999-04-19
K990406 KINGLI ACUPUNCTURE NEEDLE United Pacific Co., Ltd. MQX Class II 1999-04-16
K990711 CODAN CHEMOSPIKE Codan US Corp. LHI Class II 1999-04-13
K990541 BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE) Brightway Holdings Sdn. Bhd. LZA Class I 1999-04-09
K984059 ANGIOCATH AUTOGUARD CATHETER, INSYTE AUTOGUARD CATHETER Bd Becton Dickinson Vacutainer Systems Preanalytic FOZ Class II 1999-04-09
K990539 BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE) Brightway Holdings Sdn. Bhd. LYY Class I 1999-04-09
K990542 BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED) Brightway Holdings Sdn. Bhd. LZA Class I 1999-04-09
K990543 BRIGHTWAY BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE) Brightway Holdings Sdn. Bhd. LYY Class I 1999-04-09
K990540 BRIGHTWAY BRAND LATEX EXAMINATION GLOVE (LOW PROTEIN) Brightway Holdings Sdn. Bhd. LYY Class I 1999-04-09
K982029 SHARPS COLLECTION CONTAINER - SAF-T-SHELL American Medical Mfg., Inc. FMI Class II 1999-04-06
K982640 MEDEX 3000 SERIES SYRINGE INFUSION PUMP Medex, Inc. FRN Class II 1999-04-06
K990567 GLOBAL HEALTHCARE SELF-SEALING STERILIZATION POUCH Global Healthcare, Inc. FRG Class II 1999-04-05
K990091 S.P.A.R STERILE AMBULATORY RESERVOIR Faulding Pharmaceutical Co. MRZ Class II 1999-04-04
K990501 POWDER FREE LATEX EXAMINATION GLOVES, W/ PROTEIN LABELING CLAIM Flexitech Sdn. Bhd. LYY Class I 1999-04-02
K990502 PREPOWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) Flexitech Sdn. Bhd. LYY Class I 1999-04-02
K980745 SECOND WIND AIR PURIFIER Monagan Ent., Inc. FRA Class II 1999-04-02
K982505 ULTRA CARE NON-STERILE POWDER FREE (GREEN) NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE Tillotson Healthcare Corp. LYY Class I 1999-04-02
K990495 POWDER FREE NITRILE EXAMINATION GLOVES Flexitech Sdn. Bhd. LZA Class I 1999-04-02
K990499 PREPOWDERED NITRILE EXAMINATION GLOVES Flexitech Sdn. Bhd. LZA Class I 1999-04-02
K990703 SPOROX II STERILIZING & DISINFECTING SOLUTION Reckitt Benckiser, Inc. MED Class II 1999-03-30
K990267 POWDERED BLUE NITRILE MEDICAL EXAMINATION GLOVES Shanghai Palomar Mountain Industries, Inc. LZA Class I 1999-03-29
K990420 LAGLOVE BRAND NITRILE EXAMINATION GLOVE (POWDER FREE) La Glove (M) Sdn. Bhd. LZA Class I 1999-03-29
K990210 POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABP Mexpo Intl., Inc. LYY Class I 1999-03-29
K990415 LAGLOVE BRAND NITRILE EXAMINATION GLOVES (LIGHTLY POWDERED) La Glove (M) Sdn. Bhd. LZA Class I 1999-03-29
K990388 TUTOPLUS IV ADMINISTRATION SET Myco Medical Supplies, Inc. FPA Class II 1999-03-29
K990299 POWDER FREE BLUE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVES Shanghai Palomar Mountain Industries, Inc. LZA Class I 1999-03-29
K984039 CRANBERRY POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESSS) Cranberry (M) Sdn. Bhd. LYY Class I 1999-03-29
K990208 PERSONAL INFUSOR WITH DRUG DISPOSAL SEPTAL PORT Science Incorporated MEG Class II 1999-03-25
K990518 PEREGRINE WET SET, MODEL PD400.00 Peregrine Surgical , Ltd. FRN Class II 1999-03-25
K983794 CHEMO MINI SPIKE PLUS B. Braun of America, Inc. LHI Class II 1999-03-23
K990746 SOUTHLAND POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM Southland Products Co., Ltd. LYY Class I 1999-03-23
K990013 EVERGREEN NON-STERILE POWDER-FREE, COLORED NITRILE EXAMINATION GLOVES Yty Industry (Manjung) Sdn Bhd LZA Class I 1999-03-23
K983576 DR180-R/OXY North East Monitoring, Inc. FLL Class II 1999-03-23
K990751 SOUTHLAND POWDERFREE (POLYMER-COATED) LATEX EXAMINATION GLOVES Southland Products Co., Ltd. LYY Class I 1999-03-23
K990101 PAIN CONTROL INFUSION PUMP Sgarlato Laboratories, Inc. FRN Class II 1999-03-19
K984449 NATURAL RUBBER PRE-POWDERED COLORED & FLAVORED PATIENT EXAMINATION GLOVES WITH PROTEIN LABELLING CLAIM P.T. Irama Dinamika Latex LYY Class I 1999-03-19
K983295 BRAUN THERMOSCAN IRT3020/3500 ONE SECONS EAR THERMOMETER, MODEL IRT3020/3520 Braun AG FLL Class II 1999-03-15
K983355 SABRATEK APM-2000 AMBULATORY PATIENT MONTOR, TRANSCUTANEOUS TEMPERATURE MONITOR Sabratek Corp. FLL Class II 1999-03-12
K990283 BLUE POWDER-FREE NITRILE EXAMINATION GLOVES Hartalega Sdn Bhd LZA Class I 1999-03-09
K990453 NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN COLOR Alliance Rubber Products Sdn. Bhd. LZA Class I 1999-03-09
K983194 SPORICIDIN STERILIZING AND DISINFECTING SOLUTION (SSDS) Sporicidin Intl. MED Class II 1999-03-05
K983671 NATURAL BRAND ACUPUNCTURE NEEDLES Tcm Supply Corp. MQX Class II 1999-03-04
K984502 NERVE BLOCK INFUSION KIT I-Flow Corp. MEB Class II 1999-03-04
K984017 ALLISON MEDICAL INSULIN SYRINGE (AMIS) Allison Medical, Inc. FMF Class II 1999-03-04
K984539 FERRIS POLYMEM CALCIUM ALGINATE STERILE WOUND DRESSING Ferris Mfg. Corp. KMF Class I 1999-03-01
K982098 TUTODROP 1 AND TUTODROP 2 Myco Medical Supplies, Inc. FPA Class II 1999-03-01
K990168 MICROLIFE IT2CA1 Microlife Systems AG FLL Class II 1999-02-25
K990268 LAGLOVE BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE) La Glove (M) Sdn. Bhd. LYY Class I 1999-02-24
K990288 FREE FLOW SAFETY DEVICE, MODEL MG 245052 Teva Medical, Ltd. FPA Class II 1999-02-24
K983634 PREPARE HOME INFUSION PUMP Medical Infusion Technologies, Inc. MEB Class II 1999-02-24
K980751 SABRATEK 4040 INFUSION PUMP Sabratek Corp. FRN Class II 1999-02-24
K984441 KVO CHECK VALVE ACCESSORY, MODEL EV-0001 I-Flow Corp. FPA Class II 1999-02-22
K990228 GUTHRIE PRIME POWDER-FREE Guthrie Medicare Products (Melaka) Sdn Bhd LYY Class I 1999-02-19
K983334 NITRILE POWDER FREE EXAMINATION GLOVES Cranberry (M) Sdn. Bhd. LZA Class I 1999-02-19
K990081 DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDERED Shanghai Palomar Mountain Industries, Inc. LYZ Class I 1999-02-19

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