meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
23
Latest Decision
1999-10-29

Clearances · page 71 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K993093 HEALTH-PLUS, SANITEX, RELIANCE (50 MICROGRAMS) Pamitex Industries Sdn Bhd LYY Class I 1999-10-29
K992841 TG MEDICAL POWDERED NITRILE BLUE EXAMINATION GLOVES Tg Medical Sdn. Bhd. LZA Class I 1999-10-29
K983613 PRE-POWDERED NON-STERILE VINYL EXAMINATION GLOVES Shanghai Jiatai Plastic Products Co., Ltd. LYZ Class I 1999-10-27
K993240 SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVES Shinemound Enterprise, Inc. LYZ Class I 1999-10-27
K993097 HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATINO GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAM Pamitex Industries Sdn Bhd LYY Class I 1999-10-27
K992266 IV ADMINISTRATION SET New Alliance of Independent Medical Distributors, FPA Class II 1999-10-27
K992830 SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-FREE SHIELDMASTER NITRILE GLOVE Safeskin Corp. LZA Class I 1999-10-27
K992156 SYNSATION STERILE POWDER FREE, POLYVINYL CHLORIDE MEDICAL EXAMINATION GLOVES Ansell Perry LYZ Class I 1999-10-27
K992551 ALPHA INFUSION PUMP Advanced Infusion, Inc. MEB Class II 1999-10-27
K992601 TEMP TELLER - DIGITAL THERMOMETER, MODELS DT-101, DT-102, DT-103, DT-201, DT-202, DT-203 Oriental System Technology, Inc. FLL Class II 1999-10-27
K993258 SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVES Supermax Sdn Bhd LZA Class I 1999-10-27
K993231 SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVES Shinemound Enterprise, Inc. LYZ Class I 1999-10-27
K991543 INTRAOP CATHETER I-Flow Corp. MEB Class II 1999-10-25
K991897 CATHETER INNOVATIONS IMPLANTABLE PORT Catheter Innovations, Inc. LJT Class II 1999-10-21
K993080 AMBIDERM LATEX EXAMINATION GLOVES (VIOLET, BLUE , GREEN, AND PINK) CONTAINING 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE Medtexx Partners, Inc. LYY Class I 1999-10-20
K992468 BRAUN THERMOSCAN PRO3000 INFARED THERMOMETER Braun GmbH FLL Class II 1999-10-20
K992880 P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM Sims Deltec, Inc. LJT Class II 1999-10-19
K992523 HEALTH-PLUS SANITEX,RELIANCE PRE-POWDERED MULTI-PLY LATEX EXAMINATION GLOVE (NATURAL RUBBER LATEX-NITRILE-CONSTRUCTION W Pamitex Industries Sdn Bhd LYY Class I 1999-10-18
K990752 DERMAGRIP POWDER FREE NITRILE EXAMINATION GLOVE, NON STERILE Wrp Specialty Products Sdn. Bhd. LZA Class I 1999-10-18
K992870 POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES LABELING CONTENT: 100 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEI Alliance Rubber Products Sdn. Bhd. LYY Class I 1999-10-15
K991203 IRRIGATION OR INFUSION PUMP K PUMP Kmi Kolster Methods, Inc. FRN Class II 1999-10-15
K990750 DERMAGRIP POWDER FREE BLUE NITRILE EXAMINATION GLOVE, NON STERILE Wrp Specialty Products Sdn. Bhd. LZA Class I 1999-10-15
K992555 SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Shijiazhuang Great Vision Plastic Products Co., LT LYZ Class I 1999-10-14
K992145 ECOMED SCALP VEIN SET Greiner Meditech, Inc. FPA Class II 1999-10-14
K992865 SENSICARE XP VINYL POWDER FREE MEDICAL EXAMINATION GLOVE Maxxim Medical LYZ Class I 1999-10-13
K992768 NITRA-TOUCH STERILE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE Ansell Perry LZA Class I 1999-10-13
K992360 TG MEDICAL POWDERED NITRILE EXAMINATION GLOVES Tg Medical Sdn. Bhd. LZA Class I 1999-10-12
K991487 CIDEX OPA SOLUTION Advanced Sterilization Products MED Class II 1999-10-08
K992351 SEALOUETTE FIBRIN SEALANT APPLICATOR Biosurgical Corp. FMF Class II 1999-10-08
K991709 BROWNE CIDEX OPA INDICATOR Albert Browne , Ltd. JOJ Class II 1999-10-08
K984590 0.9% SODIUM CHLORIDE FLUSH SYRINGE Baxter Healthcare Corp FOZ Class II 1999-10-07
K992861 SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES Shijiazhuang Great Eagle Plastic Products Co., Ltd. LYZ Class I 1999-10-06
K991474 HEALTH-PLUS, SANITEX, RELIANCE, PRE-POWDERED MULTI-PLY EXAMINATION GLOVE, (NATURAL LATEX LAMINATED WITH NITRILE, EXTERNA Pamitex Industries Sdn Bhd LYY Class I 1999-10-06
K991914 SUPER SOOTHER Mart Tiller Corp. FLL Class II 1999-10-06
K992922 SENSI-PRO, DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR Shijiazhuang Hongray Plastic Products Co., Ltd. LYZ Class I 1999-10-06
K992272 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Shanghai Cosmos Corp. LYZ Class I 1999-10-01
K992734 BECTON DICKINSON SYRINGE Bd Becton Dickinson Vacutainer Systems Preanalytic MEG Class II 1999-10-01
K992271 PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES Shanghai Cosmos Corp. LYZ Class I 1999-10-01
K992117 PRE-POWDERED LATEX EXAMINATION GLOVE WITH OAT-STARCH POWDER Pamitex Industries Sdn Bhd LYY Class I 1999-09-27
K992558 NITRILE PATIENT EXAMINATION GLOVES, POWDERED, NON-STERILE Riverstone Resources Sdn Bhd LZA Class I 1999-09-27
K992810 HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE Hwa Teh Industrial Sdn. Bhd. LYY Class I 1999-09-27
K992860 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR Shijiazhuang Hongray Plastic Products Co., Ltd. LYZ Class I 1999-09-24
K992175 EXTRA-CARE LATEX PATIENT EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED Ultrawin Sdn Bhd LYY Class I 1999-09-24
K992671 QTEXX PRE-POWDERED NITRILE EXAMINATION GLOVES Latexx Partners Bhd. LZA Class I 1999-09-24
K992686 DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, BLUE COLOR Sheen More Ent. Co., Ltd. LZA Class I 1999-09-24
K992364 HEALTH-PLUS, SANITEX, RELIANCE POWER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM 73.13 MICROGRAMS O Pamitex Industries Sdn Bhd LYY Class I 1999-09-22
K992072 BOLUS ACCESSORY SET I-Flow Corp. FPA Class II 1999-09-15
K992268 NAC PRN NEEDLELESS ACCESS CONNECTOR The Kipp Group FPA Class II 1999-09-15
K992464 SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES Shijiazhuang Dilly Plastics Products Co., Ltd. LYZ Class I 1999-09-14
K992557 QUALATEX POWDERED LATEX EXAMINATION GLOVES Tan Sin Lian Industries Sdn. Bhd. LYY Class I 1999-09-14
K992730 HWA (AND) SILKTEX PRE-POWDERED LATEX EXAMINATION GLOVE Hwa Teh Industrial Sdn. Bhd. LYY Class I 1999-09-14
K992128 DASH SILICONIZED POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS Dash Medical Gloves Sdn Bhd LYY Class I 1999-09-14
K992661 CONTROL III ELITE Maril Products, Inc. LRJ Class I 1999-09-14
K992417 ROYAL SHIELD NON-STERILE POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABELING CLAIM) 200 MCGM OR LESS OF TOTAL WATER EXTR Shield Gloves Manufacturer (M) Sdn Bhd LYY Class I 1999-09-13
K992419 ROYAL SHIELD NON-STERILE BLUE COLORED POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MCGM OR Shield Gloves Manufacturer (M) Sdn Bhd LYY Class I 1999-09-13
K992418 ROYAL SHIELD NON-STERILE PINK COLORED POWDERED LATEX EXAMINATION GLOVE WITH AND WITHOUT STRAWBERRY SCENT AND WITH PROTEI Shield Gloves Manufacturer (M) Sdn Bhd LYY Class I 1999-09-13
K972708 ENDO-SPOR PLUS / HYPROCIDE Cottrell, Ltd. MED Class II 1999-09-13
K992210 SHIELDMASTER POWDERED PURPLE NITRILE EXAMINATION GLOVES Safeskin Corp. LZA Class I 1999-09-10
K992588 BLUE NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE Formosa Glove Industrial Co., Ltd. LZA Class I 1999-09-10
K992358 CORRECT TOUCH POWDER FREE 911 LATEX EXAMINATION GLOVES, (BLUE) Biopro (M) Sdn Bhd LYY Class I 1999-09-10
K992015 FREEDOM INFUSION SYSTEM Novacon Corp. MEB Class II 1999-09-10
K991969 HEALTH-PLUS, SANITEX, RELIANCE, PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (137 MCG OR LESS) Pamitex Industries Sdn Bhd LYY Class I 1999-09-09
K992091 PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750 Bio-Plexus, Inc. FMI Class II 1999-09-09
K992802 TERUMO U-100 INSULIN SYRINGE Terumo Medical Corp. FMF Class II 1999-09-09
K992044 INFUSION DYNAMICS POWER INFUSER MODEL M100B Infusion Dynamics, Inc. FRN Class II 1999-09-08
K992170 N-DEX BLUE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE Best Manufacturing Company LZA Class I 1999-09-07
K991979 SOF-SET MICRO QR INFUSION SET, MODELS 320 AND 321 Medtronic Minimed FPA Class II 1999-09-03
K991112 SAGE CONTRAST MANAGEMENT SYSTEM Sage Laboratories, Inc. FPA Class II 1999-09-02
K991777 LATEX EXAMINATION GLOVES POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL EXTRACTABLE PROTEIN) Seltom Pacific Sdn. Bhd. LYY Class I 1999-08-31
K991904 MODIFICATION OF JMS NEEDLES AND JMS SYRINGES Jms Co., Ltd. FMI Class II 1999-08-31
K991778 LATEX EXAMINATION GLOVES POLYMER COATED (POWDER-FREE) Seltom Pacific Sdn. Bhd. LYY Class I 1999-08-31
K992463 SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Shijiazhuang Dilly Plastics Products Co., Ltd. LYZ Class I 1999-08-30
K992223 HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVE Pamitex Industries Sdn Bhd LZA Class I 1999-08-30
K992162 SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM Safeskin Corp. LZC Class I 1999-08-30
K991437 WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00 Wells Johnson Co. FRN Class II 1999-08-30
K990310 CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER) Charter Medical, Ltd. CAK Class II 1999-08-30
K991729 FERRIS POLYOSTOMY STERILE WOUND DRESSING Ferris Mfg. Corp. KMF Class I 1999-08-27
K992198 URETHANE PICC LINE MODEL UPICS- Cook, Inc. FOZ Class II 1999-08-27
K983800 DN ACUPUNTURE NEEDLES Sedatelec MQX Class II 1999-08-27
K983798 SEDATELEC ASP ACUPUNCTURE NEEDLES Sedatelec MQX Class II 1999-08-27
K991508 ACUMASTER BRAND ACUPUNCTURE NEEDLE Helio Medical Supplies, Inc. MQX Class II 1999-08-27
K991507 KANGNIAN BRAND ACUPUNCTURE NEEDLE Helio Medical Supplies, Inc. MQX Class II 1999-08-27
K992496 POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED) Kossan Latex Industries(M)Sdn Bhd LZA Class I 1999-08-25
K990777 MED-RX EXTENSION SETS Benlan, Inc. FPA Class II 1999-08-25
K992165 HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE LATEX EXAMINATION GLOVE Pamitex Industries Sdn Bhd LYY Class I 1999-08-25
K992497 POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED) Kossan Latex Industries(M)Sdn Bhd LZA Class I 1999-08-25
K992062 SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVES Safeskin Corp. LZA Class I 1999-08-25
K983719 BIOSHIELD EXPRESS STERILIZATION WRAP Allegiance Healthcare Corp. FRG Class II 1999-08-25
K992672 BELMONT FLUID MANAGEMENT SYSTEM (FMS2000) Belmont Instrument Corp. FRN Class II 1999-08-24
K992299 HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED NITRILE EXAMINATION GLOVE Pamitex Industries Sdn Bhd LZA Class I 1999-08-23
K992104 PARSET, MODEL A10001E Rd Medical Mfg., Inc. FPA Class II 1999-08-23
K991254 QS DELIVERY SYSTEM Sub-Q, Inc. KYZ Class I 1999-08-23
K992107 BALDUR BRAND VINYL POWDERED EXAMINATION GLOVES General Gloves Corp. LYZ Class I 1999-08-23
K991985 COOK HIGH VOLUME INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET Cook, Inc. FPA Class II 1999-08-20
K991932 INTRAVASCULAR ADMINISTRATION SET The Kipp Group FPA Class II 1999-08-20
K991570 JOBST READY-TO-WEAR ARM SLEEVES Beiersdorf-Jobt, Inc. DWL Class II 1999-08-20
K990236 MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT Johnson & Johnson Medical, Div. of Ethicon, Inc. FOZ Class II 1999-08-20
K992032 ACRY ISLAND BORDER DRESSING, MODELS 2031, 2032, 2033 Acrymed, Inc. KMF Class I 1999-08-19
K992327 DUTECK DIGITAL CLINICAL THERMOMETER Duteck Industrial Co., Ltd. FLL Class II 1999-08-18
K992337 BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA Mexpo Intl., Inc. FMC Class I 1999-08-17

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