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510(k) Data Aggregation

    K Number
    K231435
    Device Name
    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
    Manufacturer
    Kimberly-Clark Corporation
    Date Cleared
    2023-08-28

    (103 days)

    Product Code
    LZA, LZC, OPJ, QDO
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Kimberly-Clark Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The nitrile powder free patient examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition to routine examination glove's intended use, the gloves are Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid.
    Device Description
    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 are dark magenta in color, and are single use only, non-sterile, disposable gloves. The powder-free gloves are made of synthetic copolymers of acrylonitrile and butadiene. The product will be sold as a disposable and non-sterile product in extrasmall, small, medium, large, and extra-large sizes.
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    K Number
    K231021
    Device Name
    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
    Manufacturer
    Kimberly-Clark Corporation
    Date Cleared
    2023-07-21

    (102 days)

    Product Code
    LZA, LZC, OPJ, QDO
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Kimberly-Clark Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The nitrile powder free patient examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition to routine examination glove's intended use, the gloves are Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid.
    Device Description
    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 are 245mm in length and dark magenta in color, and are single use only, non-sterile, disposable gloves. The powder-free gloves are made of synthetic copolymers of acrylonitrile and butadiene. The product will be sold as a disposable and non-sterile product in extrasmall, small, medium, large, and extra-large sizes.
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    K Number
    K223749
    Device Name
    U by Kotex® Click® Unscented Menstrual Tampons
    Manufacturer
    Kimberly-Clark Corporation
    Date Cleared
    2023-01-06

    (23 days)

    Product Code
    HEB
    Regulation Number
    884.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    Kimberly-Clark Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    U by Kotex® Click® Unscented Menstrual Tampon is an unscented tampon inserted into the vagina to absorb menstrual fluid.
    Device Description
    The U by Kotex® Click® Unscented Menstrual Tampon is a conventional unscented menstrual tampon consisting of an absorbent pledget and a telescoping three-piece plastic applicator. The device will be manufactured in Regular, Super, and Super Plus absorbencies. The absorbent pledget consists of an absorbent core of radially wound rayon ribbon compressed into a grooved cylinder with a rounded, bullet-like tip, a non-woven overwrap cover, and a rayon-polyester blend withdrawal string. The three-piece applicator consists of an outer insertion tube (barrel) with a textured grip and formed with a closed, rounded tip in a petal-like design, a clear middle telescopic tube (telescope), and an elongated insertion tube (plunger). Each tampon is individually sealed in a plastic film primary wrapper and then packaged in sealed multi-unit containers for retail sale.
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    K Number
    K200072
    Device Name
    KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid
    Manufacturer
    Kimberly-Clark Corporation
    Date Cleared
    2020-04-10

    (87 days)

    Product Code
    LZA, LZC, QDO
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Kimberly-Clark Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nitrile Powder Free patient examination glove is non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid.
    Device Description
    KIMTECH™ Purple Nitrile™ Examination Gloves, Powder Free, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric acid and Fentanyl in Simulated Gastric acid are single use only, non-sterile, disposable gloves. The powder-free gloves are made of a synthetic copolymer of acrylonitrile and butadiene with a purple color additive. The gloves are available in extra small, medium, large, and extra-large sizes.
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    K Number
    K172118
    Device Name
    U by Kotex Click Unscented Menstrual Tampons
    Manufacturer
    Kimberly-Clark Corporation
    Date Cleared
    2017-10-11

    (90 days)

    Product Code
    HEB
    Regulation Number
    884.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    Kimberly-Clark Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The U by Kotex® Click® Unscented Menstrual Tampons are inserted into the vagina to absorb menstrual fluid.
    Device Description
    The subject devices are conventional unscented menstrual tampons consisting of an absorbent pledget, an overwrap, a withdrawal string, and a plastic applicator. The absorbent pledget consists of a ribbon of rayon fibers. A rayon-polyester blend withdrawal string is placed on the ribbon and the ribbon is radially wound, then compressed into a traditional eight-groove bulletshaped pledget, overwrapped with a non-woven cover material. The tampon component is inserted into a three-piece plastic applicator consisting of an inner tube (plunger), a clear middle telescopic tube (telescope), and an outer insertion tube (barrel) formed with a closed, rounded tip. Each tampon component with applicator is wrapped in an individual plastic film wrapper, and packaged in a sealed multi-unit container for retail sale. Tampons are available in Regular, Super and Super Plus absorbencies in various counts.
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    K Number
    K143164
    Device Name
    ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set
    Manufacturer
    KIMBERLY-CLARK CORPORATION
    Date Cleared
    2014-12-02

    (29 days)

    Product Code
    BSO
    Regulation Number
    868.5120
    Why did this record match?
    Applicant Name (Manufacturer) :

    KIMBERLY-CLARK CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ON-Q* QuikBloc* Over-the-Needle Catheter Set is indicated for delivery of medication for regional anesthesia and pain management. Route of administration may be intraoperative, percutaneous, or perineural. The ON-Q* QuikBloc* Over-the-Needle Catheter Set is contraindicated for the epidural space.
    Device Description
    ON-Q* QuikBloc* Over-the-Needle (OTN) Catheter Sets are available in four product codes (20 GA x 4" Needle, 16 GA x 3" Catheter (with and without Stimulating needle); 20 GA x 6" Needle, 16 GA x 5" Catheter (with and without stimulating needle)). The kits include: 1) ON-Q* QuikBloc* Over-the-Needle Catheter Set (some models include an integrated stimulating cable) 2) Removable Needle Wing 3) Non-DEHP 24 inch Needle Extension Set, 4) Non-DEHP 6 inch Catheter Extension Set 5) Connector Securement Device 6) Occlusive Dressing 7) Adhesive Strips 8) Catheter ID label These devices are sold as disposable, sterile, single use, devices.
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    K Number
    K140539
    Device Name
    AERO BLUE PERFORMANCE SURGICAL GOWN
    Manufacturer
    KIMBERLY-CLARK CORPORATION
    Date Cleared
    2014-06-09

    (97 days)

    Product Code
    FYA
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    KIMBERLY-CLARK CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aero Blue* Performance Surgical Gowns are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Aero Blue* Performance Surgical Gowns meet the Level 3 requirements of the AAMI PB70: 2012 Liquid Barrier classifications. The Aero Blue* Performance Surgical Gowns are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.
    Device Description
    A Spunbond/Film/Spunbond/Meltblown/Spunbond design (SFSMS) that provides AAMI Level 3 liquid barrier protection in the critical zone of the gown. The back of the gown is a SMS (spunbond/meltblown/spunbond fabric that is air-breathable and provides AAMI Level 1 liquid barrier protection.
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    K Number
    K122653
    Device Name
    MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES
    Manufacturer
    KIMBERLY-CLARK CORPORATION
    Date Cleared
    2013-06-26

    (299 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    KIMBERLY-CLARK CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kimberly-Clark* MIC-KEY* SF Low Profile Gastrostomy Tube and Accessories are indicated for use in patients who require long term feeding, are unable to tolerate oral feeding, who are at low risk for aspiration, require gastric decompression and/or medication delivered directly into the stomach through a secured (initial placement) or formed (replacement) stoma. Kimberly-Clark* MIC-KEY* SF Continuous Feed Extension Set is indicated for use with the MIC-KEY* SF Low Profile Gastrostomy Tube to facilitate nutrition, medication delivery, and gastric decompression. Kimberly-Clark* MIC-KEY* SF Bolus Feed Extension Set is indicated for use with the MIC-KEY* SF Low Profile Gastrostomy Tube to facilitate nutrition, medication delivery, and gastric decompression. Kimberly-Clark* MIC-KEY* SF Patient Starter Kit is indicated to provide necessary components to begin enteral feeding after placement of the Kimberly-Clark* MIC-KEY* SF Gastrostomy Tube. Kimberly-Clark* MIC-KEY* SF Over-the-Wire Stoma Measuring Device is indicated for measuring the length of a stoma prior to placement of a low profile feeding tube.
    Device Description
    Low profile Gastrostomy feeding tube and accessories to facilitate nutrition, medication delivery, and gastric decompression for single patient use. The Kimberly-Clark* MIC-KEY* SF Low Profile Gastrostomy Tube external feeding head, feeding catheter, and disc-shaped retention balloon are manufactured with polyurethane. The feeding catheter is inserted into the stomach through a secured or formed stoma and is held in place with a retention balloon that is filled with sterile or distilled water. The device is provided with feeding catheter outer diameters that range from 10Fr to 24Fr, and with feeding tube lengths that range from 0.8cm to 6.0cm to fit different stoma diameters and lengths, respectively. The device incorporates a balloon fill indicator to alert the user when the balloon is not optimally inflated and incorporates an extension set connector that snaps with an audible double click that helps confirm that the connection of the extension set is secure. In addition, the feeding port includes a one-way dome valve that does not require a closure cap/strap. The Kimberly-Clark* MIC-KEY* SF Bolus Feed Extension Set and Kimberly-Clark* MIC-KEY* SF Continuous Feed Extension Set engage to the feeding port using a snap-in connector and are made from DEHP-free materials. The feed valve and extension set ports have been designed to help prevent misconnections with Luer style connectors in alignment with ISO 80369-1 requirements. The Kimberly-Clark* MIC-KEY* SF Over-the-Wire Stoma Measuring Device consists of a head, catheter, retention balloon, that are composed of polvurethane.
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    K Number
    K120650
    Device Name
    POISE PERSONAL LUBRICANT
    Manufacturer
    KIMBERLY-CLARK CORPORATION
    Date Cleared
    2012-07-11

    (131 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    KIMBERLY-CLARK CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Poise Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex condoms but is compatible with polyisoprene and polyurethane condoms.
    Device Description
    Poise Personal Lubricant is a water soluble, clear, colorless, viscous liquid composed of purified water, hydroxyethyl cellulose (Natrosol 250), propylene glycol, benzoic acid and sodium hydroxide. Poise Personal Lubricant is presented as a non-sterile product. It is neither a contraceptive nor a spermicide and is sold over-the-counter. The product is packaged in a seventy-four ml plastic, cylindrical pump bottle placed inside a display carton. The outside of the display carton contains a tamper evident seal. Poise Personal Lubricant is a non-greasy and fragrance-free formulation which contains only United States Pharmacopeia (USP) or National Formulary (NF) ingredients.
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    K Number
    K113333
    Device Name
    KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS
    Manufacturer
    KIMBERLY-CLARK CORPORATION
    Date Cleared
    2012-05-11

    (179 days)

    Product Code
    BTR
    Regulation Number
    868.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    KIMBERLY-CLARK CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KIMVENT* MICROCUFF* Endotracheal Tubes for Adults are indicated for airway management by nasal or oral intubation of the trachea in adult patients.
    Device Description
    The Kimberly-Clark* KimVent* Microcuff* Endotracheal Tubes for Adults are available in sizes 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 10.0 mm. They are available as Magill and made with an ultra-thin polyurethane cuff, referred to as the MicroCuff*.
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