Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 16
- Latest Decision
- 1989-08-09
Clearances · page 119 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K891499 | PATIENT EXAMINATION GLOVES (LATEX) | Promedica Sdn. Bhd. | LYY | Class I | 1989-08-09 |
| K894147 | VISULIN TRANSPARENT ADHESIVE DRESSING | James River Corp. | KGX | Class I | 1989-08-09 |
| K892136 | PATIENT EXAMINATION GLOVES (LATEX) | Beijing Light Industrial Products Import & Export | LYY | Class I | 1989-08-09 |
| K891445 | LATEX EXAMINATION GLOVES | Superior Healthcare Group, Inc. | LYY | Class I | 1989-08-09 |
| K893602 | GLASS MERCURY FILLED THERMOMETERS | Smith & Nephew United, Inc. | FLK | Class II | 1989-08-08 |
| K890757 | C-VAPOR STERILIZATION INDICATOR, CHEMICAL VAPOR | Spsmedical Supply Corp. | JOJ | Class II | 1989-08-07 |
| K890760 | STRIP, STERILIZATION INDICATOR, E.O. GAS | Spsmedical Supply Corp. | JOJ | Class II | 1989-08-07 |
| K890359 | RESUBMITTED STC SERIES 8600 AUTOCLAVE | Sterilizer Technologies Corp. | FLE | Class II | 1989-08-07 |
| K890765 | STRIP, STERILIZATION INDICATOR; STEAM OR E.O. GAS | Spsmedical Supply Corp. | JOJ | Class II | 1989-08-07 |
| K885350 | PREEMICARE SERIES 2000 INFANT WARMER | Preemicare Corp. | FMT | Class II | 1989-08-07 |
| K890759 | STRIP, STERILIZATION INDICATOR; STEAM | Spsmedical Supply Corp. | JOJ | Class II | 1989-08-07 |
| K890763 | LABEL, STERILIZATION INDICATOR; DUAL STEAM/E.O.GAS | Spsmedical Supply Corp. | JOJ | Class II | 1989-08-07 |
| K890764 | LABEL, STERILIZATION INDICATOR; RADIATION | Spsmedical Supply Corp. | JOJ | Class II | 1989-08-07 |
| K890761 | STRIP, STERILIZATION INDICATOR; DRY HEAT | Spsmedical Supply Corp. | JOJ | Class II | 1989-08-07 |
| K894014 | LATEX EXAMINATION GLOVES | Hsin Hung Co. , Ltd. | LYY | Class I | 1989-08-07 |
| K890755 | SEALING TAPE, STERILIZATION INDICATOR; STEAM | Spsmedical Supply Corp. | JOJ | Class II | 1989-08-07 |
| K890758 | DRY HEAT STERILIZATION INDICATOR TAPE | Spsmedical Supply Corp. | JOJ | Class II | 1989-08-07 |
| K892772 | NON-STERILE PATIENT EXAMINATION GLOVES | Care-Pro Industries, Inc. | LYY | Class I | 1989-08-04 |
| K892981 | PATIENT EXAMINATION GLOVES | Lapoma Gloves Industries Sdn. Bhd. | LYY | Class I | 1989-08-03 |
| K892971 | LATEX EXAM GLOVES | P.C. Commercial, Inc. | LYY | Class I | 1989-08-03 |
| K893900 | PRIMAPORE I.V. | Smith & Nephew United, Inc. | KGX | Class I | 1989-08-03 |
| K891184 | PATIENT EXAMINATION GLOVES (LATEX) | Healthcare Gloves Sdn Bhd | LYY | Class I | 1989-08-03 |
| K892940 | PRECIOUS LITE MODEL 4224 | E & B Technologies, Inc. | LBI | Class II | 1989-08-03 |
| K893264 | LATEX EXAMINATION GLOVES | P.T. Kreasi Bhojwanis | LYY | Class I | 1989-08-03 |
| K890862 | AMBULATORY INFUSION PUMP | Medfusion, Inc. | FRN | Class II | 1989-08-03 |
| K892982 | PATIENT LATEX EXAMINATION GLOVES | Ataro Industri (Malaysia) Sdn Bhd | LYY | Class I | 1989-08-03 |
| K893918 | LATEX EXAM GLOVES(MFG: LINGSHUN INDUSCOMM LTD LIAB | P.C. Commercial, Inc. | LYY | Class I | 1989-08-01 |
| K894307 | LAWANA PATIENT EXAMINATION GLOVES | Viri Imports, Inc. | LYY | Class I | 1989-08-01 |
| K884577 | PROCEDURE READY TRAYS | Professional Medical Services | FOZ | Class II | 1989-08-01 |
| K893262 | LATEX EXAMINATION GLOVES | S.C. Rubber Co., Ltd. | LYY | Class I | 1989-08-01 |
| K892788 | PATIENT EXAMINATION GLOVES (LATEX) | Dawin Investments , Ltd. | LYY | Class I | 1989-08-01 |
| K894192 | PATIENT EXAMINATION GLOVES | Royal Pacific Intl. Trade, Inc. | LYY | Class I | 1989-08-01 |
| K892782 | PATIENT EXAMINATION GLOVES (LATEX) | Chung Yang Rubber Works (M) Sdn. Bhd. | LYY | Class I | 1989-08-01 |
| K892977 | ACCUTOUCH PATIENT EXAM GLOVES | Thai Medical Industries Co., Ltd. | LYY | Class I | 1989-08-01 |
| K891340 | PATIENT EXAMINATION GLOVES (LATEX) | Partech Co., Inc. | LYY | Class I | 1989-07-31 |
| K893076 | PROSON PATIENT EXAMINATION GLOVES | Long Far Industry Co., Ltd. | LYY | Class I | 1989-07-31 |
| K891285 | PATIENT EXAMINATION GLOVES (LATEX) | Buildvest Holdings Sdn Bhd | LYY | Class I | 1989-07-31 |
| K891804 | HYGEIA EXAMINATION GLOVES | Rubtex , Ltd. | LYY | Class I | 1989-07-31 |
| K891665 | PATIENT EXAMINATION GLOVES (LATEX) | Clinical Supply | LYY | Class I | 1989-07-31 |
| K891495 | PATIENT EXAMINATION GLOVES (LATEX) | Salcon Rubber Sdn Bhd | LYY | Class I | 1989-07-31 |
| K891629 | PATIENT EXAMINATION GLOVES (LATEX) | Union Rubber Gloves Co., Ltd. | LYY | Class I | 1989-07-31 |
| K890968 | VINYL EXAMINATION GLOVES (MFG. SALZGITTER MOREX) | Interpro Intl., Inc. | LYZ | Class I | 1989-07-31 |
| K891496 | PATIENT EXAM GLOVES (LATEX) MFG. CHINA XINXING | B.C. Young Intertrade Corp. | LYY | Class I | 1989-07-31 |
| K891787 | PATIENT EXAMINATION GLOVES (LATEX) | Socoil Latex Products Sdn Bhd | LYY | Class I | 1989-07-31 |
| K891809 | PATIENT EXAMINATION GLOVES (LATEX) | Firestone Financial Corp. | LYY | Class I | 1989-07-31 |
| K893143 | LATEX EXAM GLOVES (MFG. GUANGDONG ZHONGSHAN) | Guangzhou Chemicals Import & Export Corp. | LYY | Class I | 1989-07-31 |
| K891668 | PATIENT EXAMINATION GLOVES (LATEX) | Influx Pacific Sdn. Bhd. | LYY | Class I | 1989-07-31 |
| K892980 | LONGFORTUNE PATIENT EXAM GLOVES | Long Fortune Industries , Ltd. | LYY | Class I | 1989-07-31 |
| K891808 | PATIENT EXAMINATION GLOVES (LATEX) | Anro Corp. Sdn Bhd | LYY | Class I | 1989-07-31 |
| K891497 | PATIENT EXAM GLOVES (LATEX) MFG. HUA GUANG | B.C. Young Intertrade Corp. | LYY | Class I | 1989-07-31 |
| K891494 | ESSEREL PATIENT EXAMINATION GLOVES (LATEX) | Karthik Engineering, Inc. | LYY | Class I | 1989-07-31 |
| K891747 | PATIENT EXAMINATION GLOVES (LATEX) | Arden Sales, Inc. | LYY | Class I | 1989-07-31 |
| K893144 | LATEX EXAM GLOVES (MFG. GUANGZHOU NO. 11 RUBBER) | Guangzhou Chemicals Import & Export Corp. | LYY | Class I | 1989-07-31 |
| K893487 | LIFECARE 75 CONTROLLER | Abbott Laboratories | LDR | Class II | 1989-07-28 |
| K891862 | PATIENT EXAM GLOVES (MFG. HEBEI XINJI & XINJI WEN) | China Xinxing Corp. , Ltd. | LYY | Class I | 1989-07-28 |
| K890786 | IVSK09 CALIBRATION KIT AN ACCESSORY TO IV7000/7200 | Valleylab, Inc. | FRN | Class II | 1989-07-28 |
| K891246 | PATIENT EXAMINATION GLOVES (LATEX) | Penfirst Corp. Sdn. Bhd. | LYY | Class I | 1989-07-28 |
| K892016 | PATIENT EXAMINATION GLOVES (LATEX) | Winhace Trading, Inc. | LYY | Class I | 1989-07-28 |
| K894195 | LATEX EXAMINATION GLOVES | Jiahn Chiaur Enterprise Co., Ltd. | LYY | Class I | 1989-07-28 |
| K892489 | PATIENT EXAM GLOVES (MFG. UNITED LION RUBBER) | Chori America, Inc. | LYY | Class I | 1989-07-28 |
| K893825 | LATEX EXAMINATION GLOVES | Frank W. Winne & Son, Inc. | LYY | Class I | 1989-07-28 |
| K891861 | PATIENT EXAM GLOVES (MFG. TIANJIN & JINGJIN) | China Xinxing Corp. , Ltd. | LYY | Class I | 1989-07-28 |
| K892606 | PATIENT EXAMINATION GLOVES (LATEX) | Tritech Mfg. Industries, Inc. | LYY | Class I | 1989-07-28 |
| K893057 | MEDI, ULTRA, CURI EXAM GLOVES | Sinjaca Inc. Dba Sic Medical & Surgical Supplies | LYY | Class I | 1989-07-28 |
| K891505 | PATIENT EXAMINATION GLOVES (LATEX) | Taiwan Link Sdn Bhd | LYY | Class I | 1989-07-28 |
| K893756 | SURGICARE (R) SPECIALTY EXAMINATION GLOVES | Inter Continental Health Care | LYY | Class I | 1989-07-28 |
| K892461 | NON-STERILE LATEX EXAMINATION GLOVES | Rahn Laboratories | LYY | Class I | 1989-07-28 |
| K891275 | PATIENT EXAMINATION GLOVES (LATEX) | M.R. Rubber Industries Sdn. Bhd. | LYY | Class I | 1989-07-28 |
| K893120 | KIT, INTRAVENOUS EXTENSION TUBING | Island Medical | FPA | Class II | 1989-07-27 |
| K890120 | SYRINGE INFUSION PUMP | Medfusion, Inc. | FRN | Class II | 1989-07-27 |
| K892906 | 60 MICROBORE EXTENSION SET W/ANTI-SIPHON VALVE | Bd Becton Dickinson Vacutainer Systems Preanalytic | FRN | Class II | 1989-07-25 |
| K894205 | TECNOL SILK STRIP | Tecnol New Jersey Wound Care, Inc. | FPX | Class I | 1989-07-25 |
| K891023 | SIEMENS CEILING STAND 800F, 800 AND 810 | Siemens Medical Electronics | LDQ | 1989-07-25 | |
| K892429 | INJECTION PORT FOR---INTERMITTENT INJECTION | The Medi-Dose Group | FPA | Class II | 1989-07-25 |
| K893864 | LATEX EXAMINATION GLOVES | In Medicine, Inc. | LYY | Class I | 1989-07-24 |
| K892438 | KENDALL CURITY INTRAVASCULAR CUT DOWN TUBES | The Kendal Co. | FPA | Class II | 1989-07-24 |
| K893295 | LATEX EXAMINATION GLOVES | Lee AH Sheng Ent. Co., Ltd. | LYY | Class I | 1989-07-24 |
| K893296 | LATEX EXAMINATION GLOVES | Midas Intl. Development Corp. | LYY | Class I | 1989-07-24 |
| K892440 | KENDALL CURITY EXTENSION TUBES | The Kendal Co. | FPA | Class II | 1989-07-24 |
| K892575 | VINYL PATIENT EXAMINATION GLOVES | Foodhandler, Inc. | LYZ | Class I | 1989-07-24 |
| K892379 | THE POUCH GROIN & ABDOMINAL STRESS AID | Kuhn Industries | FSD | Class I | 1989-07-20 |
| K892867 | ULCERCARE | Jobst Institute, Inc. | DWL | Class II | 1989-07-20 |
| K890858 | PATIENT EXAMINATION GLOVES | Rejuvena Ent. Co. , Ltd. | LYY | Class I | 1989-07-14 |
| K892570 | PATIENT EXAMINATION GLOVES (LATEX) | Ansell Pacific, Inc. | LYY | Class I | 1989-07-14 |
| K893241 | LATEX EXAM GLOVES | Semodal Jaya Sdn. Bhd. | LYY | Class I | 1989-07-14 |
| K893551 | LATEX EXAMINATION GLOVES | Mlb Holdings Sdn. Bhd. | LYY | Class I | 1989-07-14 |
| K893090 | PATIENT EXAMINATION GLOVES (LATEX) | Thai Chong Chemical Industrial Co., Ltd. | LYY | Class I | 1989-07-14 |
| K893347 | LATEX EXAMINATION GLOVES | Changzhou Foreign Economic Technical and Trading | LYY | Class I | 1989-07-14 |
| K892497 | PATIENT EXAMINATION GLOVES (LATEX) | Ching Feng Blinds Co., Ltd. | LYY | Class I | 1989-07-14 |
| K892573 | LATEX PATIENT EXAMINATION GLOVES | Encore Products, Inc. | LYY | Class I | 1989-07-14 |
| K892580 | CARETOUCH EXAMINATION GLOVES | James River Corp. | LYY | Class I | 1989-07-14 |
| K892166 | NON-STERILE PATIENT EXAM GLOVES (LATEX) | Ergo Intl., Ent., Inc. | LYY | Class I | 1989-07-14 |
| K892986 | PATIENT EXAMINATION GLOVE | Larkspur Consulting Co. | LYY | Class I | 1989-07-14 |
| K891967 | PATIENT EXAMINATION GLOVES (NATURAL LATEX) | Butex Products (M'Sia) Sdn.Bhd | LYY | Class I | 1989-07-14 |
| K892958 | TACCTILE PATIENT EXAMINATION GLOVES | Trans American Chemical Corp. | LYY | Class I | 1989-07-14 |
| K891840 | VINYL EXAMINATION GLOVES | Maxcare, Inc. | LYZ | Class I | 1989-07-14 |
| K891625 | NONSTERILE LATEX EXAMINATION GLOVES | World Spring Industries Corp. | LYY | Class I | 1989-07-14 |
| K893178 | LATEX EXAMINATION GLOVES | Intl. Marketing Assoc. Corp. | LYY | Class I | 1989-07-14 |
| K891110 | LATEX PATIENT EXAMINATION GLOVES | I Horng Industrial Co., Ltd. | LYY | Class I | 1989-07-14 |
| K893102 | VINYL EXAMINATION GLOVES | Samson Taiwan Corp. | LYY | Class I | 1989-07-14 |
15,723 clearances in the General Hospital panel. Data: openFDA.