meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
24
Latest Decision
1999-08-17

Clearances · page 72 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K992200 TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA GREEN, CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE Shen Wei (Usa), Inc. LYY Class I 1999-08-17
K991958 KLOUT SHAMPOO AND LICE COMBING PRETREATMENT KIT Kiel Laboratories, Inc. LJL Class I 1999-08-13
K991920 DERMAPHYLYX HYDROPHILIC FOAM WOUND DRESSING Dermaphylyx, Inc. KMF Class I 1999-08-12
K984569 AB2 MED-FLO SOLUTION SET Ab2 Medical Products, Llp FPA Class II 1999-08-12
K991776 NITRILE EXAMINATION GLOVES POWDER FREE (WHITE) Seltom Pacific Sdn. Bhd. LZA Class I 1999-08-11
K991779 NITRILE EXAMINATION GLOVES POWDER FREE (BLUE) Seltom Pacific Sdn. Bhd. LZA Class I 1999-08-11
K990883 LAGLOVE BRAND BLUE COLOLRED NITRILE EXAMINATION GLOVE (POWDERED) La Glove (M) Sdn. Bhd. LZA Class I 1999-08-10
K992428 ACCUTOUCH POWDER FREE NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE Tillotson Healthcare Corp. LYY Class I 1999-08-09
K991981 NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE, DARK BLUE COLOR Alliance Rubber Products Sdn. Bhd. LZA Class I 1999-08-05
K991845 PATIENT EXAMINATION GLOVES, NITRILE POWDER FREE, TURQUOISE,NON-STERILE. Omnigrace , Ltd. LZA Class I 1999-08-05
K991846 PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON-STERILE Omnigrace , Ltd. LZA Class I 1999-08-05
K992017 DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE Shanghai Antares Industries, Inc. LYZ Class I 1999-08-05
K992289 VINYL POWDERED EXAM GLOVE / CAT.# 15-020 Vitalcare Group, Inc. LYZ Class I 1999-08-04
K992126 CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM Circon Corp. GCX Class II 1999-08-03
K991933 DERMAPHYLYX FOAM ISLAND DRESSING Dermaphylyx, Inc. KMF Class I 1999-07-30
K991615 POLYURETHANE POWDER FREE DENTAL EXAMINATION GLOVE, POLYURETHANE POWDER FREE MEDICAL EXAMINATION GLOVE Maxxim Medical LZA Class I 1999-07-30
K992177 NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LARGE Pt. Berlian Glovindo LZA Class I 1999-07-29
K984506 SD-100 SKYEAR THERMOMETER Skylark Device Co., Ltd. FLL Class II 1999-07-29
K991591 BIOTHANE PATIENT RESTRAINT Bioplastics FMQ Class I 1999-07-29
K992100 PVC (POLYVINYL CHLORIDE) SYNTHETIC EXAMINATION GLOVES, POWDERED Shanghai Palomar Mountain Industries, Inc. LYZ Class I 1999-07-29
K992300 QUICK-SERTER, MODEL 395 Medtronic Minimed KZH Class II 1999-07-29
K992206 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Shanghai China Star Corp LYZ Class I 1999-07-29
K991951 SAFESKIN SYNTHETIC BINYO POWDER-FREE POLYMER COATED EXAMINATION GLOVES (GREEN, WHITE) Safeskin Corp. LYZ Class I 1999-07-26
K984060 LUER ACCESS INJECTION SITE Baxter Healthcare Corp FPA Class II 1999-07-26
K992205 PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES Shanghai China Star Corp LYZ Class I 1999-07-23
K991609 DERMAPHYLYX SUPER ABSORBENT FIBER DRESSING Dermaphylyx, Inc. KMF Class I 1999-07-20
K991608 DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING Dermaphylyx, Inc. KMF Class I 1999-07-20
K992122 TRU-TOUCH PF VINYL POWDER FREE EXAMINATION GLOVE Maxxim Medical LYZ Class I 1999-07-15
K991695 DYNAREX NON-WOVEN SPONGE Dynarex Corp. KMF Class I 1999-07-15
K991694 DYNAREX DRAIN SPONGE Dynarex Corp. KMF Class I 1999-07-15
K991616 CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) Hartalega Sdn Bhd LYY Class I 1999-07-14
K991509 PRO-PORTION CLEANER/DISINFECTANT Sultan Chemists, Inc. LRJ Class I 1999-07-14
K992031 LATEX EXAMINATION GLOVE POWDER FREE, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER SOLUBLE PROTEIN) Shanghai Changzheng Latex Factory LYY Class I 1999-07-12
K991276 PASS/FAIL CHALLENGE PACK Propper Mfg. Co., Inc. JOJ Class II 1999-07-12
K990761 TUTTNAUER MINI CONTAINER CASSETTE, TUTTNAUER STANDARD CASE CASSETTE Tuttnauer U.S.A Co, Ltd. FRG Class II 1999-07-09
K991554 GLOVCO, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) Glovco (M) Sdn. Bhd. LYY Class I 1999-07-09
K991624 POLYMER COAT,POWDER FREE, LATEX EXAMINATION GLOVES Smart Glove Corp. Sdn Bhd LYY Class I 1999-07-09
K991225 MTI 1 ML SYRINGE Micro Therapeutics, Inc. FMF Class II 1999-07-08
K991849 NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER EXTRAC Seal Polymer Industries Bhd. LYY Class I 1999-07-07
K991275 WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS Mckinley, Inc. FRN Class II 1999-07-01
K991821 NITRILE EXAMINATION GLOVE, POWDERED, BLUE Ning BO Yujiang Rubber & Plastic Co. LZA Class I 1999-07-01
K990496 ANESFLOW-DUAL DRIP IV INFUSION SET Innovative Design Assoc. FPA Class II 1999-07-01
K991457 DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE Shanghai Palomar Mountain Industries, Inc. LYZ Class I 1999-07-01
K990461 MCKINLEY SP DISPOSABLE INFUSION PUMP Mckinley, Inc. MEB Class II 1999-06-30
K991759 MAERSK MEDICAL CONTOUR INFUSION SET Maersk Medical A/S FPA Class II 1999-06-25
K991689 LATEX EXAMINATION GLOVES (POWDER FREE) Usg Healthguard Sdn Bhd LYY Class I 1999-06-24
K991653 INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM Rymed Technologies, Inc. FPA Class II 1999-06-24
K984116 HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400C Abatement Technologies, Inc. FRF Class II 1999-06-24
K991690 LATEX EXAMINATION GLOVES (PRE POWDERED) Usg Healthguard Sdn Bhd LYY Class I 1999-06-24
K990020 TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC Te ME NA S.A.R.L. FMF Class II 1999-06-24
K991752 BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN PE Brightsway Holdings Sdn Bhd LYY Class I 1999-06-23
K991750 BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN Brightsway Holdings Sdn Bhd LYY Class I 1999-06-23
K991749 LAGLOVE BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN PE La Glove (M) Sdn. Bhd. LYY Class I 1999-06-23
K991748 LAGLOVE BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150 MLGM OR LESSOF WATER EXTRACTABLE PROTEIN PER G La Glove (M) Sdn. Bhd. LYY Class I 1999-06-23
K991013 MINIMED 407C INFUSION PUMP, MODEL 407C Medtronic Minimed FRN Class II 1999-06-23
K991744 SMART SHIELD NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES WITH BUBBLEGUM SCENT Shield Gloves Manufacturer (M) Sdn Bhd LZA Class I 1999-06-23
K991743 ROYAL SHIELD NON-STERILE BUBBLE GUM SCENTED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (5O Shield Gloves Manufacturer (M) Sdn Bhd LYY Class I 1999-06-23
K991746 ROYAL SHIELD POWDER-FREE PINEAPPLE SCENTED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR Shield Gloves Manufacturer (M) Sdn Bhd LYY Class I 1999-06-23
K990876 BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDERED) Brightway Holdings Sdn. Bhd. LZA Class I 1999-06-23
K991745 ROYAL SHIELD NON-STERILE POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH A PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM Shield Gloves Manufacturer (M) Sdn Bhd LYY Class I 1999-06-23
K991304 HEALTH + AID PREMIUM POWDER FREE NITRILE EXAMINATION GLOVES, BLUE M.R.G. Industries Sdn. Bhd. LZA Class I 1999-06-23
K991155 CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES C.V. Anlis Abadi International LYY Class I 1999-06-21
K983893 POWDERED VINYL EXAMINATION GLOVE Shijiazhuang Brethern Plastic Co., Ltd. LYZ Class I 1999-06-21
K983856 POWDER FREE VINYL EXAMINATION GLOVES Shijiazhuang Brethern Plastic Co., Ltd. LYZ Class I 1999-06-21
K990186 SYNTHETIC POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES Shanghai Intco. Plastic & Rubber Products Co., Ltd. LZA Class I 1999-06-21
K991305 HEALTH + AID PREMIUM POWDER FREE LATEX EXAMINATION GLOVES M.R.G. Industries Sdn. Bhd. LYY Class I 1999-06-21
K991742 NON-STERILE, POWDER FREE, POLYMER COATED LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN CLAIM OF 50 MICROGRAM O Yty Industry (Manjung) Sdn Bhd LYY Class I 1999-06-21
K991513 HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO I-Flow Corp. FPA Class II 1999-06-21
K991153 MEDTEXX POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTA\ Medtexx Industries (Thai) Co. , Ltd. LYY Class I 1999-06-21
K991406 TERUMO SURFLO FLEX I.V. CATHETER AND TERUMO SURFLASH I.V. CATHETER Terumo Medical Corp. FOZ Class II 1999-06-16
K991376 DAHEDI INSULIN INFUSION PUMP Disetronic Medical Systems LZG Class II 1999-06-15
K991675 MODIFICATION OF: STERRAD BI TEST PACK Advanced Sterilization Products FRC Class II 1999-06-15
K991599 CADD ADMINISTRATION SET Sims Deltec, Inc. FPA Class II 1999-06-15
K984576 K-PACK II (HYPODERMIC NEEDLE) 23G X 1, MODEL KN-2325RB, K-PACK II NEEDLE (HYPODERMIC NEEDLE) 25G X 1, MODEL KN-2525RB, K Terumo Europe N.V. FMI Class II 1999-06-14
K991758 MONOJECT INSULIN SYRINGE The Kendal Co. FMF Class II 1999-06-14
K991686 LATEX EXAMINATION GLOVES, POWDER FREE WITH PROTEIN LABELING CLAIM (50 MCG OR LESS) Arista Latindo Industrial Ltd. P.T LYY Class I 1999-06-11
K990246 STERI-PAK LF BOWIE-DICK TEST PACK Steritec Products Mfg Co, Inc. JOJ Class II 1999-06-10
K991418 BROWNE MVI ETHYLENE OXIDE INDICATOR Albert Browne , Ltd. JOJ Class II 1999-06-10
K991255 CADD-TPN ADMINISTRATION SET, MODEL 21-7071 Sims Deltec, Inc. FPA Class II 1999-06-09
K991301 CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1 Sims Deltec, Inc. FPA Class II 1999-06-09
K990801 MINIMED 508 INSULIN PUMP Medtronic Minimed LZG Class II 1999-06-08
K990889 AUTODOSE INFUSION SYSTEM Tandem Medical, Inc. MEB Class II 1999-06-03
K991680 SOFTINJECT Androsystems Srl KZH Class II 1999-06-03
K991511 POWDERED NITRILE EXAMINATION GLOVE, WHITE (NON-COLORED) Perusahaan Getah Asas Sdn. Bhd. LZA Class I 1999-06-03
K981860 A P HARNESS Paraworks Enterprise, Ltd. KMK Class I 1999-06-03
K990668 POWDER FREE BLUE NITRILE GLOVE Tg Medical Sdn. Bhd. LZA Class I 1999-06-03
K991612 STERISHARP 2.5-GALLON RSDC, MODEL #RSDC2.5G Sterilogic Waste Systems, Inc. MMK Class II 1999-05-28
K991462 QTEXX POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED Latexx Partners Bhd. LYY Class I 1999-05-28
K990488 SENSIFLEX POWDERFREE LATEX EXAMINATION GLOVE Terang Nusa Sdn Bhd LYY Class I 1999-05-28
K991158 LATEX EXAMINATION GLOVES- POWDER FREE, SIZES EXTRA SMALL, SMALL,MEDIUM,LARGE,EXTRA LARGE P. T. Tata Rubberindo Industries LYY Class I 1999-05-28
K991640 HEALTH AID PREMIUM PRE-POWDERED NITRILE EXAMINATION GLOVES M.R.G. Industries Berhad LZA Class I 1999-05-28
K984614 NORMAL SALINE FLUSH SYRINGE Rocap Div. of Sabratek Corp. FOZ Class II 1999-05-27
K990963 RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE) Riverstone Resources Sdn Bhd LZA Class I 1999-05-26
K991415 SUPERGLOVES, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES Supermax Sdn Bhd LYY Class I 1999-05-26
K984497 TEMP TELLER-INFRARED TYMPANIC THERMOMETER, MODELS TT-200, TT-201 Oriental System Technology, Inc. FLL Class II 1999-05-26
K991493 BLUE POWDER-FREE NITRILE EXAMINATION GLOVES Masju Sdn. Bhd. LZA Class I 1999-05-26
K991039 EASYSAFE RETRACTING NEEDLE SYRINGE Saf-T-Med, Inc. FMF Class II 1999-05-21
K990878 BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDER FREE) Brightway Holdings Sdn. Bhd. LZA Class I 1999-05-21
K990882 LAGLOVE BRAND COLORED NITRILE EXAMINATION GLOVES (POWDER FREE) La Glove (M) Sdn. Bhd. LZA Class I 1999-05-21
K984270 VAPO-SOLUTION FOR USE IN MDT HARVEY CHEMICLAVE STERILIZERS, MODELS 5000, 5500, AND 6000 Roger L. Goodman, D.D.S., P.C. MED Class II 1999-05-20

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