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510(k) Data Aggregation

    K Number
    K200150
    Device Name
    Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl)
    Manufacturer
    Medline Industries Inc
    Date Cleared
    2020-10-26

    (278 days)

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

    Medline Industries Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. It has also been tested for use against Fentanyl Citrate, ASTM D6978-05 (Reapproved 2019, Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs). Drugs Tested: Fentanyl Citrate, 100mcg/2mL Breakthrough Time (Minutes) >240 min
    Device Description
    The Medline Powder-Free Orange Nitrile Patient Examination Gloves (Tested for use with Fentanyl) are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are nitrile, powderfree, ambidextrous, and orange-colored with a beaded cuff. The proposed device is offered in in the following sizes: Small, Medium, Large, Extra-Large, Extra Extra-Large.
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    K Number
    K201290
    Device Name
    Medline DeNovo 4Pro Electrical Stimulation Device
    Manufacturer
    Medline Industries Inc
    Date Cleared
    2020-09-21

    (130 days)

    Product Code
    IPF, GZI, GZJ, HCC, KPI
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Medline Industries Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For EMG mode: - Relaxation muscle training and muscle re-education For NMES (also known as STIM) mode: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion - Muscle Re-Education For TENS mode: - Symptomatic relief and management of chronic (long-term), intractable pain - Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain For EMG Triggered Stimulation (ETS) mode (nonimplanted electrical continence device only): - Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detruser muscles through reflexive mechanisms and strengthening of pelvic floor muscles - Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles (abdominal or gluteal) For FES - Helps to relearn voluntary motor functions of the extremities
    Device Description
    The Medline DeNovo 4Pro Electrical Stimulation Device is a four-channel, hand-held, non-sterile, battery-powered, multi-patient device intended to be used by adult patients under the supervision of a trained clinical healthcare provider. The proposed device is controlled by a MCU (Microcontroller Unit) that supports device functionality, display functionality. Bluetooth, and audio. The subject device is intended to be used for muscle stimulation for the purposes of urinary incontinence treatment, pain management, muscle strengthening and training, as well as muscle relaxation and re-education. The device is a TENS (Transcutaneous Electrical Nerve Stimulator), ETS (Electrical Muscle Stimulator) and NMES (Neuromuscular Electrical Stimulator also known as STIM) including FES (Functional Electrical Stimulation) with EMG biofeedback. The Medline DeNovo 4Pro Electrical Stimulation Device features four channels for NMES (Neuromuscular Electrical Stimulator also known as STIM), with two that utilize Electromyography (EMG). Multiple stimulation protocols are pre-programed for three general categories of applications: muscle strengthening (i.e. biofeedback training), pain control, and neuromuscular re-education. Each category contains up to eight protocols to address the specific needs of the patient. The Medline DeNovo 4Pro Electrical Stimulation Device is designed to provide safe and effective electrical stimulation by sending small electrical currents to underlying nerves and muscle groups via electrodes applied on the skin or through a vaginal probe (for incontinence treatment protocols only). The parameters of the unit are controlled by the +/push buttons and touch screen (refer to Figure 1 and 2 below). The pre-programed protocols on the Medline DeNovo 4Pro Electrical Stimulation Device are all fully automatic and controlled by the device, and it is also capable of manual control in hand switch mode. The levels of intensity are adjustable to the needs of the patient and treatments prescribed by their healthcare providers. The device can be used with or without linkage to a PC and includes a color, pressure sensitive touch-screen. This unit also comes with a wireless charger that is capable of charging during NMES (Neuromuscular Electrical Stimulator also known as STIM) via inductive charging. Batteries will not need to be regularly replaced, and charging will be made so much easier. The proposed device also has Bluetooth capabilities that will allow the device to connect to a computer for screen mirror imaging.
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