Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 14
- Latest Decision
- 1989-04-26
Clearances · page 124 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K891718 | LATEX EXAMINATION GLOVES | Liu'S Glove Corp. | LYY | Class I | 1989-04-26 |
| K891799 | PATIENT EXAMINATION GLOVES (VINYL) | Tak Ent., Inc. | LYZ | Class I | 1989-04-26 |
| K891441 | NON-STERILE LATEX EXAMINATION GLOVES | Arista Latindo Industrial Ltd. P.T | LYY | Class I | 1989-04-26 |
| K891969 | PATIENT EXAMINATION GLOVES (LATEX) | Protective Glove Co. | LYY | Class I | 1989-04-26 |
| K885055 | INSU COOL | Dynex Trading Co. | LDQ | 1989-04-26 | |
| K890176 | EXTENSION SETS WITH AND WITHOUT FILTERS | Medical Support Systems | FPA | Class II | 1989-04-26 |
| K891659 | WISE & SAFE PATIENT EXAMINATION GLOVES (LATEX) | Wise Industries Sdn. Bhd. | LYY | Class I | 1989-04-26 |
| K891448 | PATIENT EXAMINATION GLOVES (LATEX) | Naturalex Rubber Products (M) Sdn Bhd | LYY | Class I | 1989-04-26 |
| K891711 | PATIENT EXAMINATION GLOVES (LATEX) | E-Full Industrial , Ltd. | LYY | Class I | 1989-04-26 |
| K891223 | PATIENT EXAMINATION GLOVES (LATEX) | Sin Super Holdings Sdn Bhd | LYY | Class I | 1989-04-26 |
| K891304 | PATIENT EXAMINATION GLOVES (LATEX) | B & L Ent. Co. | LYY | Class I | 1989-04-26 |
| K884786 | EAR IRRIGATION SET 101 (EARIGATOR) | Physicians Supply Co. | KYZ | Class I | 1989-04-26 |
| K891710 | PATIENT EXAMINATION GLOVES (LATEX) | Klh Medical, Inc. | LYY | Class I | 1989-04-26 |
| K891798 | PATIENT EXAMINATION GLOVES (LATEX) | Li-Fa Chemical Industry Co., Ltd. | LYY | Class I | 1989-04-26 |
| K890907 | ROYAL SHIELD LATEX EXAMINATION GLOVES(TM) | Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc. | LYY | Class I | 1989-04-26 |
| K891305 | PATIENT EXAMINATION GLOVES (VINYL) | B & L Ent. Co. | LYY | Class I | 1989-04-26 |
| K891846 | PATIENT EXAMINATION GLOVES (LATEX) | Shing Shuenn Co. , Ltd. | LYY | Class I | 1989-04-26 |
| K892365 | TA TA LATEX EXAM GLOVE | Ta TA Industrial Co., Ltd. | LYY | Class I | 1989-04-26 |
| K891738 | PERFECT TOUCH PATIENT EXAM GLOVES (LATEX) | Young Innovations, LLC Dba Plak Smacker | LYY | Class I | 1989-04-26 |
| K891795 | DISPOSABLE LATEX EXAM GLOVES | Eagle Medical, Inc. | LYY | Class I | 1989-04-26 |
| K891365 | LATEX EXAMINATION GLOVES, NON-STERILE | China National Medicines & Health Prod. I/E Corp. | LYY | Class I | 1989-04-26 |
| K891506 | FREEPINHO VINYL EXAM GLOVES | Reliance Industrial Co., Ltd. | LYZ | Class I | 1989-04-26 |
| K891258 | PATIENT EXAMINATION GLOVES (LATEX) | Aek Rubber Product Sdn. Bhd. | LYY | Class I | 1989-04-25 |
| K890851 | PATIENT EXAMINATION GLOVES (NON-STERILE VINYL) | Daw Shin Industrial Co., Ltd. | LYZ | Class I | 1989-04-25 |
| K891704 | PATIENT EXAMINATION GLOVES (LATEX) | Executive Commodities Exchange Co. | LYY | Class I | 1989-04-25 |
| K891343 | GIGLO PATIENT EXAMINATION GLOVE (LATEX) | Giant Glove Industrial Co., Ltd. | LYY | Class I | 1989-04-25 |
| K892096 | PATIENT EXAMINATION GLOVE (LATEX) | Grand Universe Trading Co., Ltd. | LYY | Class I | 1989-04-25 |
| K891344 | OLIVE BRAND, SILKY TOUCH PATIENT EXAMINATION GLOVE | Uni-Attach, Inc. | LYY | Class I | 1989-04-25 |
| K891646 | TOPLAS VINYL PATIENT EXAMINATION GLOVE | Toplas Industrial Co., Ltd. | LYZ | Class I | 1989-04-25 |
| K884325 | SUBCLAVIAN HEMODIALYSIS CATH. W/VITACUFF DEVICE | Bd Becton Dickinson Vacutainer Systems Preanalytic | FOZ | Class II | 1989-04-25 |
| K892115 | PROTEX PATIENT EXAMINATION GLOVES (LATEX) | Pt Nusa Dipa Perdana | LYY | Class I | 1989-04-25 |
| K891645 | TAK, VINYL PATIENT EXAMINATION GLOVES | Tak Ent., Inc. | LYZ | Class I | 1989-04-25 |
| K891267 | PATIENT EXAMINATION GLOVES (LATEX) | Genie Rubber Products Co. | LYY | Class I | 1989-04-24 |
| K890484 | HI-LO TEMP GENERAL PURPOSE TEMPERATURE PROBE | Mallinckrodt Anesthesia Products | FLL | Class II | 1989-04-21 |
| K890518 | SINGLE LUMEN S.E.A.-PORT VASCULAR ACCESS SYSTEM | Harbor Medical Devices, Inc. | LJT | Class II | 1989-04-21 |
| K884841 | RETRACTABLE PISTON SYRINGE W/LUER-LOCK COLLAR | Hall Medical Laboratories | FMF | Class II | 1989-04-21 |
| K890751 | ACCI-GUARD(TM) I.V. CATHETER PLACEMENT UNIT | Medical Safety Products, Inc. | FOZ | Class II | 1989-04-21 |
| K891072 | INTRAVASCULAR ADMINISTRATION SET | Multi-Med, Inc. | FPA | Class II | 1989-04-21 |
| K890282 | RESUBMITTED ABBOTT LIFECARE MODEL 3 HB PUMP | Abbott Laboratories | FRN | Class II | 1989-04-19 |
| K891983 | CAM-WRAP(TM) NEW STERILIZATION PROCEDURE | Medical Dynamics, Inc. | KCT | Class II | 1989-04-19 |
| K890976 | PATIENT EXAMINATION GLOVE | Cranberry (M) Sdn. Bhd. | LYY | Class I | 1989-04-18 |
| K890850 | CENTURY DISOSABLE LATEX GLOVE | Century Force Co. , Ltd. | LYY | Class I | 1989-04-17 |
| K891740 | PATIENT EXAM GLOVES (LATEX) MFG. TIANJIN KANG BAO | Brilliant Ray Intl., Inc. | LYY | Class I | 1989-04-14 |
| K891215 | FAST WRAP #M 101 | Pro-Safe Professional Linens, Inc. | KCT | Class II | 1989-04-14 |
| K891739 | PATIENT EXAM GLOVE (LATEX) MFG. TIANJIN JI COUNTY | Brilliant Ray Intl., Inc. | LYY | Class I | 1989-04-14 |
| K891637 | PATIENT EXAMINATION GLOVES (LATEX) | Powercrest (M) Sdn. Bhd. | LYY | Class I | 1989-04-14 |
| K883609 | ACCES. PACKAGE FOR USE W/CARDIOGEN-82 GENERATOR | Squibb Diagnostics | FRN | Class II | 1989-04-14 |
| K891636 | PATIENT EXAMINATION GLOVES (LATEX) | Broadland Rubber Industries Sdn Bhd | LYY | Class I | 1989-04-14 |
| K891213 | SURGICAL INSTRUMENT POUCH #M102 | Pro-Safe Professional Linens, Inc. | KCT | Class II | 1989-04-14 |
| K891214 | DENTAL SURGICAL WRAP #3007 A,B,C | Pro-Safe Professional Linens, Inc. | KCT | Class II | 1989-04-14 |
| K891264 | PATIENT EXAMINATION GLOVES (LATEX) | Safeskin Corp. | LYY | Class I | 1989-04-13 |
| K891255 | CURITY DISPOSABLE LATEX GLOVES | Kendall Healthcare Products Co. Div.Of Tyco Health | LYY | Class I | 1989-04-13 |
| K891884 | PATIENT EXAMINATION GLOVES (LATEX) | Duflex Products Sdn. Bhd. | LYY | Class I | 1989-04-13 |
| K891639 | PATIENT EXAMINATION GLOVES (LATEX) | Tak Ent., Inc. | LYY | Class I | 1989-04-13 |
| K891112 | PATIENT EXAMINATION GLOVE (LATEX) | Medglove | LYY | Class I | 1989-04-13 |
| K891356 | PATIENT EXAMINATION GLOVES (VINYL) | Pm Gloves, Inc. | LYZ | Class I | 1989-04-13 |
| K891632 | PATIENT EXAMINATION GLOVES (LATEX) | Rank Rubber Industries Sdn Bhd | LYY | Class I | 1989-04-13 |
| K891868 | PATIENT EXAMINATION GLOVE (LATEX) | Bber Sound Rubber Industrial Co., Ltd. | LYY | Class I | 1989-04-12 |
| K891877 | PATIENT EXAMINATION GLOVES (LATEX) | W.A. Rubbermate Co. C/O Orient Intl. Trading, Inc. | LYY | Class I | 1989-04-12 |
| K891850 | AMMEX LATEX EXAMINATION GLOVES | Ammex Corp. | LYY | Class I | 1989-04-11 |
| K891566 | VINYL EXAM GLOVES (MFG. AM GLOVES CO. LTD.) | Neo-Sigma, Inc. | LYZ | Class I | 1989-04-11 |
| K891885 | PATIENT EXAMINATION GLOVES (LATEX) | Alfaseal Sdn. Bhd. | LYY | Class I | 1989-04-11 |
| K891568 | VINYL EXAM GLOVES (MFG. JM GLOVES CO. LTD.) | Neo-Sigma, Inc. | LYZ | Class I | 1989-04-11 |
| K891860 | PATIENT EXAMINATION GLOVES (VINYL) | Cypress Medical Products, Ltd. | LYZ | Class I | 1989-04-11 |
| K891866 | RUBBER LATEX PATIENT EXAMINATION GLOVES | Amsia Intl., Inc. | LYY | Class I | 1989-04-11 |
| K891567 | VINYL EXAM GLOVES (MFG. PRECIOUS MOUNTAIN ENT.) | Neo-Sigma, Inc. | LYZ | Class I | 1989-04-11 |
| K891883 | PATIENT EXAMINATION GLOVES (LATEX) | China National Machinery & Equipment Import & Expo | LYY | Class I | 1989-04-11 |
| K891128 | PATIENT EXAMINATION GLOVE | Jensen Union Ent. Co., Ltd. | LYZ | Class I | 1989-04-11 |
| K891854 | SKIN ANGEL BRAND (PATIENT EXAM GLOVES - LATEX) | Unidus Corp. | LYY | Class I | 1989-04-11 |
| K890129 | PLEUR-EVAC(R) A-8020--INFANT CHEST DRAINAGE SYSTEM | Deknatel, Inc. | GCX | Class II | 1989-04-10 |
| K890293 | AIDE-A-PATIENT (NURSING HOME BED) | Morton Metalcraft Co. | FNL | Class II | 1989-04-07 |
| K891648 | GOLD CLASS, GRANDTEX, LATEX EXAMINATION GLOVES | Harry Panzer Intl. Corp. | LYY | Class I | 1989-04-07 |
| K891743 | PATIENT EXAMINATION GLOVES (LATEX) | Dispotex Industries Sdn. Bhd. | LYY | Class I | 1989-04-07 |
| K891017 | PATIENT EXAMINATION GLOVE | Paramount Products, Inc. | LYY | Class I | 1989-04-06 |
| K890987 | VINYL PATIENT EXAMINATION GLOVE | Jm Gloves Co., Ltd. | LYZ | Class I | 1989-04-06 |
| K890356 | LATEX EXAMINATION GLOVES NON-STERILE | Quest Intl., Inc. | LYY | Class I | 1989-04-06 |
| K891260 | PATIENT EXAMINATION GLOVES (LATEX) | The Glove Outlet, Inc. | LYY | Class I | 1989-04-06 |
| K891508 | PATIENT EXAMINATION GLOVES (LATEX) | Safeway Products, Inc. | LYY | Class I | 1989-04-06 |
| K891507 | PATIENT EXAMINATION GLOVES (LATEX) | Purna Bina Sdn Bhd | LYY | Class I | 1989-04-06 |
| K890593 | PATIENT EXAMINATION GLOVE | Industri Getah Jacon | LYY | Class I | 1989-04-05 |
| K890426 | CONSUMMATE AIR THERAPY BED | Health Products, Inc. | FNL | Class II | 1989-04-05 |
| K890202 | TELE-TEMP THERMOMETER | Rocky Mountain Medical Corp. | FLL | Class II | 1989-04-05 |
| K891300 | NON-STERILE PATIENT EXAMINATION GLOVE | Shun Thai Rubber Gloves Industry Co., Ltd. | LYY | Class I | 1989-04-05 |
| K891416 | PATIENT EXAMINATION GLOVES (LATEX) | Sampson Development Corp. | LYY | Class I | 1989-04-04 |
| K884511 | SAFE MULTIPORT INJECTOR | L & W Ent. | FPA | Class II | 1989-04-04 |
| K891329 | STERILE PATIENT EXAMINATION GLOVES | Galaxy Intl., Inc. | LYY | Class I | 1989-04-04 |
| K891330 | NON-STERILE PATIENT EXAMINATION GLOVES | Galaxy Intl., Inc. | LYY | Class I | 1989-04-04 |
| K890982 | BUTTERFLY GLOBE (PATIENT EXAMINATION GLOVE) | O.L. Trading, Inc. | LYY | Class I | 1989-04-04 |
| K890986 | VINYL PATIENT EXAMINATION GLOVE | Precious Mountain Ent. Corp. | LYZ | Class I | 1989-04-04 |
| K891649 | PATIENT EXAMINATION GLOVES (LATEX) | Lic-Orthion | LYY | Class I | 1989-04-04 |
| K890431 | PLEUR-EVAC(R) A-8000--ADULT/PEDIATRIC CHEST DRAIN | Deknatel, Inc. | GCX | Class II | 1989-04-04 |
| K890473 | NEEDLE GUARD(TM) | Martech Medical Products, Inc. | FMI | Class II | 1989-04-03 |
| K891322 | DISPOSABLE LATEX EXAMINATION GLOVES | Duflex Products Sdn. Bhd. | LYY | Class I | 1989-03-31 |
| K890971 | PATIENT EXAMINATION GLOVE, LATEX | Yaung Jenn Co., Ltd. | LYY | Class I | 1989-03-31 |
| K890340 | INTRAVASCULAR ADMINISTRATION SET | Multi-Med, Inc. | FPA | Class II | 1989-03-31 |
| K891501 | PATIENT EXAMINATION GLOVES (LATEX) | Tan Chong Rubber Gloves Sdn Bhd | LYY | Class I | 1989-03-31 |
| K891368 | PATIENT EXAMINATION GLOVES (LATEX) | Zest Mark Industrial Co., Ltd. | LYY | Class I | 1989-03-31 |
| K891546 | PATIENT EXAMINATION GLOVES (LATEX) | Ap Intl., Inc. | LYY | Class I | 1989-03-31 |
| K891307 | PATIENT EXAMINATION GLOVES (LATEX) | Five Star Rubber Products | LYY | Class I | 1989-03-31 |
| K890591 | PATIENT EXAMINATION GLOVE | Marcon Rubber Industry Sdn. Bhd. | LYY | Class I | 1989-03-30 |
15,723 clearances in the General Hospital panel. Data: openFDA.