Kimberly-Clark Corporation
Neenah, WI, US
KIMBERLY-CLARK CORPORATION appears in FDA device records in Neenah, WI. FDA records list 122 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 35 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 122FDA records hold 122 510(k) clearances for Kimberly-Clark Corporation between 1978 and 2023. The busiest year on record is 1986, with 11. The most recent is 2023, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 7 |
| 1979 | 5 |
| 1980 | 3 |
| 1981 | 2 |
| 1982 | 1 |
| 1983 | 2 |
| 1984 | 2 |
| 1985 | 8 |
| 1986 | 11 |
| 1987 | 5 |
| 1988 | 9 |
| 1989 | 6 |
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 1 |
| 1998 | 3 |
| 2001 | 2 |
| 2003 | 2 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 2 |
| 2008 | 6 |
| 2009 | 8 |
| 2010 | 6 |
| 2011 | 6 |
| 2012 | 7 |
| 2013 | 4 |
| 2014 | 4 |
| 2017 | 1 |
| 2020 | 2 |
| 2023 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K231435 | KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | LZA | Substantially Equivalent | |
| K231021 | KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | LZA | Substantially Equivalent | |
| K223749 | U by Kotex® Click® Unscented Menstrual Tampons | HEB | Substantially Equivalent | |
| K202416 | Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid, Kimtech Prizm Xtra Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid | LZA | Substantially Equivalent | |
| K200072 | KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid | LZA | Substantially Equivalent | |
| K172118 | U by Kotex Click Unscented Menstrual Tampons | HEB | Substantially Equivalent | |
| K143164 | ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set | BSO | Substantially Equivalent | |
| K140963 | KIMGUARD SMART-FOLD STERILIZATION WRAP | FRG | Substantially Equivalent | |
| K141294 | U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS | HEB | Substantially Equivalent | |
| K140539 | AERO BLUE PERFORMANCE SURGICAL GOWN | FYA | Substantially Equivalent | |
| K131879 | KC 300 SURGICAL MASK | FXX | Substantially Equivalent | |
| K131841 | KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE | LZA | Substantially Equivalent | |
| K131254 | KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE | BTR | Substantially Equivalent | |
| K122653 | MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES | KNT | Unknown | |
| K120985 | KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING | BTR | Substantially Equivalent | |
| K120650 | POISE PERSONAL LUBRICANT | NUC | Substantially Equivalent | |
| K112805 | KIMGUARD ONE-STEP STERILIZATION WRAP | FRG | Substantially Equivalent | |
| K113333 | KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS | BTR | Substantially Equivalent | |
| K113340 | KIMBERLY-CLARK CHILD'S FACEMASK | OXZ | Substantially Equivalent | |
| K113423 | KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE | LZA | Substantially Equivalent | |
| K112300 | KIMGUARD SMART-FOLD* STERILIZATION WRAP | FRG | Substantially Equivalent | |
| K112562 | BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER | OYI | Substantially Equivalent | |
| K113036 | U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS | HEB | Substantially Equivalent | |
| K111402 | KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL | FXX | Substantially Equivalent | |
| K112635 | U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS | HEB | Substantially Equivalent | |
| K103150 | KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK | OXZ | Substantially Equivalent | |
| K110455 | KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS | FXX | Substantially Equivalent | |
| K103406 | MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS | FYA | Substantially Equivalent | |
| K103311 | U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS | HEB | Substantially Equivalent | |
| K102666 | KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM | KKX | Substantially Equivalent | |
| K102032 | KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) - 12 STERILE PAIRS | LZA | Substantially Equivalent | |
| K101596 | KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER- | LZC | Substantially Equivalent | |
| K093115 | KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100 | FYA | Substantially Equivalent | |
| K091749 | U BY KOTEX CLICK* UNSCENTED TAMPONS, MODEL ABSORBENCY: REGULAR, SUPER AND SUPER PLUS | HEB | Substantially Equivalent | |
| K093312 | KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL ACCESS DILATION SYSTEM | KGC | Substantially Equivalent | |
| K092167 | KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500, KC600 | FRG | Substantially Equivalent | |
| K091685 | KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC 500, KC600 | FRG | Substantially Equivalent | |
| K091357 | MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400 | FYA | Substantially Equivalent | |
| K082554 | KIMGUARD STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500 AND KC600 | FRG | Substantially Equivalent | |
| K082177 | KIMGUARD ONE-STEP STERILIZATION WRAP | FRG | Substantially Equivalent | |
| K083234 | KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100 | KKX | Substantially Equivalent | |
| K080795 | ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN | FYA | Substantially Equivalent | |
| K081089 | KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIM | LZC | Substantially Equivalent | |
| K081260 | KIMBERLY-CLARK *LAVENDER* NITRILE POWER-FREE EXAM GLOVES | LZA | Substantially Equivalent | |
| K081027 | KIMBERLY-CLARK STERLING NITRILE POWDER-FREE EXAM GLOVE (STERILE) | LZA | Substantially Equivalent | |
| K080821 | MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE | BTR | Substantially Equivalent | |
| K080253 | KIMBERLY-CLARK INTRODUCER KITS | KGC | Unknown | |
| K052870 | INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200 | NZP | Substantially Equivalent | |
| K052824 | KIMBERLY-CLARK PROCEDURE GOWN | FYA | Substantially Equivalent | |
| K051347 | KIMBERLY-CLARK* STERLING* NITRILE POWDER-FREE EXAMINATION GLOVE | LZA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003701733 | 3003701733 | KIMBERLY-CLARK CORPORATION | 2100 WINCHESTER RD., NEENAH, WI 54956 US | 2026 | |
| 3009527814 | 3009527814 | Kimberly-Clark Corporation | 2010 N. Rulon White Blvd., Ogden, UT 84404 US | 2026 | |
| 9710006 | 1000312280 | Kimberly-Clark Inc. | 1200-50 Burnhamthorpe Road West, Mississauga Ontario L5B 3Y5 CA | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KMFBandage, Liquid
- KMEBedding, Disposable, Medical
- FYFCap, Surgical
- BSOCatheter, Conduction, Anesthetic
- FXPCover, Shoe, Operating-Room
- KKXDrape, Surgical, Antimicrobial
- EYQGarment, Protective, For Incontinence
- FMEGown, Examination
- FYCGown, Isolation, Surgical
- FYAGown, Surgical
- JOJIndicator, Physical/Chemical Sterilization Process
- LYYLatex Patient Examination Glove
- NUCLubricant, Personal
- FXXMask, Surgical
- KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
- LZCMedical Glove, Specialty
- OYINon-Bronchoscopic Bronchoalveolar Lavage Catheter
- NUQPad, Menstrual, Reusable
- HHLPad, Menstrual, Scented, Scented-Deodorized
- NRCPad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile
- HHDPad, Menstrual, Unscented
- OXZPediatric/Child Facemask
- HHWPessary, Vaginal
- LZAPolymer Patient Examination Glove
- NZPSealant, Microbial
- BWPShoe And Shoe Cover, Conductive
- HHTSpatula, Cervical, Cytological
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)
- FXOSuit, Surgical
- DWJSystem, Thermal Regulating
- HILTampon, Menstrual, Scented, Scented-Deodorized
- HEBTampon, Menstrual, Unscented
- KGCTube, Gastro-Enterostomy
- BTRTube, Tracheal (W/Wo Connector)
- KNTTubes, Gastrointestinal (And Accessories)
- LYZVinyl Patient Examination Glove
- FRGWrap, Sterilization
Recall records
Showing 25 of 35| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0751-2019 | U by Kotex Sleek, Regular Tampons, 3 Count | Potential for tampon to come apart upon removal. | Class II | Terminated | |
| Z-0750-2019 | U by Kotex Sleek, Regular/Super Tampons, 34 Count Multipack | Potential for tampon to come apart upon removal. | Class II | Terminated | |
| Z-0749-2019 | U by Kotex Sleek, Regular Tampons, 34 Count | Potential for tampon to come apart upon removal. | Class II | Terminated | |
| Z-0748-2019 | U by Kotex Sleek, Regular Tampons, 18 Count | Potential for tampon to come apart upon removal. | Class II | Terminated | |
| Z-0850-2014 | Kimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22, Length 100 mm, Active Tip 10 mm, Distributed in the US by Kimberly-Clark,Product code PMF22-100-10 The product is used to create lesions in nervous tissue when used with the Kimberly-Clark radiofrequency generator and probes. | Product may contain a cannula with an active tip length of only 5mm rather than 10mm as indicated on the label. | Class II | Terminated | |
| Z-0518-2014 | Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD LOR Syringe (BD Code 405198) Product Usage: The device is designed to provide regional anesthesia. The device may contain syringes, needles and drugs | Kimberly-Clark Single Shot Epidural Pain Management Trays contain the BD 7 mL Epilor plastic Luer-Lok LOR Syringes under recall by Becton Dickinson (BD) because the product may stall or stick when traveling within the barrel of the syringe. | Class II | Terminated | |
| Z-0995-2013 | KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm), Square. Intended to be used to enclose another medical device that is to be sterilized by a health care provider. | Some individual container filter units might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier. | Class II | Terminated | |
| Z-0258-2013 | MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. | Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled. | Class II | Terminated | |
| Z-0257-2013 | ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. | Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled. | Class II | Terminated | |
| Z-2181-2012 | Kimberly Clark Patient Warming System - Model 1000 Control Unit. Kimberly Clark Patient Warming System - Model 1000 Control Unit and Energy Transfer Pads is a thermal regulating system, indicated for monitoring and controlling patient temperature. | A defect of the "fuse holder" can lead to a Control Unit failure that may cause the device to lose its ability to warm and maintain set temperature and may also result in excessive heat with the fuse assembly that could lead to the generation of smoke. | Class II | Terminated | |
| Z-0938-2012 | KIMBERLY CLARK MIC GASTRO-ENTERIC FEEDING TUBE, 22F. Gastro-Enteric Feeding Tube. | The product is misbranded, i.e. the Gastric (center) port may be mislabeled as the Jejunal port, and the Jejunal (side) port mislabeled as the Gastric port. | Terminated | ||
| Z-0393-2012 | Kotex Natural Balance Security tampons, regular absorbency, unscented. packaged in 18 count or 36 count retail containers. Consumer Services, Kimberly-Clark Corp. Dept. KNBTR-18, P.O. Box 2020, Neenah, WI 54957-2020 USA. To absorb menstrual or other vaginal discharge. | A limited number of Kotex Natural Balance Security Unscented Tampons, regular absorbency, are being recalled after a raw material contaminated with a bacterium, Enterobacter sakazakii, was found when testing the plunger portion of the applicator. | Terminated | ||
| Z-2836-2011 | Kimberly-Clark, Three Quarter Drape, Non sterile/Disposable, Surgical drape. | Metal shavings were found within the folded portion of the surgical drape. | Terminated | ||
| Z-2425-2012 | ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Kimberly-Clark ULTRA Fabric Reinforced Surgical Gown is a sterile, single use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. | The impacted product was not intended for commercial distribution to end users. | Class III | Terminated | |
| Z-0921-2011 | Ultra Surgical Gown, X-Large with Polypropylene Fabric and Towel, Reference number 95121-35, Single use only, Sterile, Made in Honduras. | Product was not properly sterilized. | Terminated | ||
| Z-0920-2011 | Ultra Surgical Gown, Large with Polypropylene Fabric and Towel, Reference number 95111-35, Single use only, Sterile, Made in Honduras. | Product was not properly sterilized. | Terminated | ||
| Z-0451-2013 | Kimberly-Clark Patient Warming System - Model 1000 Control Unit The product is a thermal regulating system, indicated for monitoring and controlling patient temperature. | Error 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately. | Class II | Terminated | |
| Z-2416-2012 | Kimberly-Clark MIC PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes intended for a non-surgical "pull" endoscopic placement technique. The PEG tube is held in place during use with an external retention disk. | The placement guidewire diameter is too large and does not pass-through the introducer needle during the placement procedure of the PEG Feeding Tube. | Class II | Terminated | |
| Z-2415-2012 | Kimberly-Clark MIC Safety PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes intended for a non-surgical "pull" endoscopic placement technique. The PEG tube is held in place during use with an external retention disk. | The placement guidewire diameter is too large and does not pass-through the introducer needle during the placement procedure of the PEG Feeding Tube. | Class II | Terminated | |
| Z-2018-2012 | MicroCool Breathable Impervious Gown with Secure Fit Surgical, (Large and X-Large), Made in Honduras. The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to be worn by heathcare professionals to help protect the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter. | Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns. | Class II | Terminated | |
| Z-2017-2012 | MicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, Made in Honduras. The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to be worn by heathcare professionals to help protect the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter. | Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns. | Class II | Terminated | |
| Z-1645-2009 | Kimberly-Clark, Synthetic Powder Free Vinyl Exam Gloves, Small, Medium and Large, 100 gloves per box, Non-Sterile, For Medical Use, Catalogue Numbers: 55031, 55032, and 55033. Distributed by Kimberly Clark LLC, Roswell, GA | The product may contain defects/holes reducing the product's effectiveness as a barrier. | Terminated | ||
| Z-1144-2007 | Kimberly Clark Microcuff Endotracheal Tube, Pediatric Oral Curved, sizes 3.0mm, 3.5mm, 4.0mm and 4.5mm, Rx Only, Sterile, Manufacturer: Kimberly-Clark NV Belgicastraat 13, 1930 Zaventem, Belgium, Made in Malaysia | The tubes may kink during use which may impede or prevent ventilation. | Terminated | ||
| Z-1143-2007 | Kimberly-Clark Microcuff Endotracheal Tube, Pediatric Oral/Nasal Magill, sizes 3.0mm, 3.5mm, 4.0mm, and 4.5mm, Rx Only, Sterile, Manufacturer: Kimberly-Clark NV Belgicastraat 13, 1930 Zaventem, Belgium, Made in Malaysia | The tubes may kink during use which may impede or prevent ventilation. | Terminated | ||
| Z-1242-06 | Kimberly-Clark/Ballard medical R2 triangle shaped non-radiolucent multifunction electrode products for adults. | The tinfoil in the triangle electrodes has the potential to develop cracks which may hinder electrical flow and product performance during defibrillation. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain