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510(k) Data Aggregation

    K Number
    K212464
    Device Name
    Dukal Corporation AAMI Level 4 Open-Back Protective Gown
    Manufacturer
    Dukal Corporation
    Date Cleared
    2022-03-30

    (236 days)

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

    Dukal Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dukal AAMI Level 4 Open-Back Protective Gowns are intended to protect health care personnel and patients from the transfer of microorganisms, body fluids, and particulate material. These gowns are not intended for use in the operating room. The Dukal AAMI Level 4 Open-Back Protective Gown meets the barrier protection requirements of AAMI Level 4 per ANSI/A AMI PB70, Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities, but has an open back which is non-protective. These gowns are single use, disposable medical devices provided non-sterile.
    Device Description
    Dukal AAMI Level 4 Open-Back Protective Gowns are intended to protect health care personnel and patients from the transfer of microorganisms, body fluids, and particulate material These gowns are not intended - for use in the operating room. The gowns are available on Regular and X-Large sizes. Dukal AAMI Level 4 Open-Back Protective Gowns are made with laminate material (SMS nonwoven material with polyethylene film). All gowns are blue, with neck removal feature, belt ties, and thumb hook cuff sleeves. These gowns are single use, disposable devices, that are provided non-sterile.
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    K Number
    K210321
    Device Name
    Dukal Corporation Level 1 Pediatric Face Mask
    Manufacturer
    Dukal Corporation
    Date Cleared
    2022-03-29

    (418 days)

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

    Dukal Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dukal Level 1 Pediatric Face Masks are intended to be worn by the patient/child to cover the nose and mouth to provide a barrier for the respiratory tract from microorganisms, body fluids, and particulate material. Recommended ages are 4-12. The face mask is specifically for use with patients whose age or illness may prevent them from taking necessary precautions in situations where transfer of microorganisms, body fluids, and particulates can occur. The face masks are recommended for use in a healthcare setting with appropriate adult supervision. The Dukal Level 1 Pediatric Face Masks are single use, disposable devices that are provided non-sterile.
    Device Description
    Pediatric face masks are intended to be worn by the patient/child to cover the nose and mouth to provide a barrier for the respiratory tract from microorganisms, body fluids, and particulate material. The mask is available in the following product sizes: Regular Size (14.5x9cm) and Extra Small Size (12.5x8cm). The Dukal Level 1 Pediatric Face Mask (both sizes) are composed of three layers of materials and pleated to form the mask. The inner layer is composed of Polypropylene (Spunbond), the middle layer is Polypropylene (Meltblown) filter material, and the outer layer is polypropylene (Spunbond). The masks (both sizes) are held in place on wearer with knitted polyester/spandex elastic ear loop and contain a malleable aluminum nosepiece strip. The masks (both sizes) have decorative patterns, printed with colored inks.
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    K Number
    K203237
    Device Name
    Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown
    Manufacturer
    Dukal Corporation
    Date Cleared
    2022-03-18

    (500 days)

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

    Dukal Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, Dukal AAMI Level 3 Reinforced Surgical Gown and Sterile AAMI Level 3 Surgical Gown met the requirements for Level 3 classification; Dukal Sterile AAMI Level 4 Surgical Gown and Sterile AAMI Level 4 Splicing Surgical Gown met the requirements for Level 4 classification. The Dukal Sterile AAM Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown are single use, disposable medical devices, and are provided sterile.
    Device Description
    Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown are single use, disposable medical devices, and are provided sterile. Each type of Surgical Gown is available in six product sizes: M, L, XL, XXL, XXXL and XXXL-XL. Dukal Sterile AAMI Level 3 Reinforced Surgical Gown and Sterile AAMI Level 3 Surgical Gown are made with SMS nonwoven material. The Dukal Sterile AAMI Level 4 Surgical Gown and Sterile AAMI Level 4 Splicing Surgical Gown are made with BVB material. Only the Dukal Sterile AAMI Level 3 Reinforced Surgical Gown is reinforced with laminated material. Dukal Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, Sterile AAMI Level 4 Splicing Surgical Gown are non-reinforced. Only the Sterile AAMI Level 4 Splicing Surgical gown has a different material for the back of the gown (SMS nonwoven fabric). The back of the gown for the Sterile AAMI Level 4 Surgical gown is made with BVB material. All gowns are blue, with hook and loop closures, belt ties, and knitted cuff sleeves.
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    K Number
    K201732
    Device Name
    Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On
    Manufacturer
    Dukal Corporation
    Date Cleared
    2021-02-16

    (236 days)

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

    Dukal Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dukal Corporation Level 3 Surgical Face Masks are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
    Device Description
    Face Masks intended to protect health care patients and personnel from the transfer of microorganisms, body fluids and particulate material.
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    K Number
    K201421
    Device Name
    Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield; Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons
    Manufacturer
    Dukal Corporation
    Date Cleared
    2021-02-05

    (252 days)

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

    Dukal Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dukal Corporation Level 2 Surgical Mask with Ear Loops, Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield, and Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.
    Device Description
    Face Masks intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.
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    K Number
    K113689
    Device Name
    DUKAL LUBRICATING JELLY
    Manufacturer
    DUKAL CORPORATION
    Date Cleared
    2012-05-04

    (141 days)

    Product Code
    KMJ
    Regulation Number
    880.6375
    Why did this record match?
    Applicant Name (Manufacturer) :

    DUKAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dukal Sterile Lubricating Jelly is a medical device intended for medical purposes, to lubricate body orifices to facilitate entry of diagnostic devices when a sterile field is required.
    Device Description
    The Dukal Sterile Lubricating Jelly is a clear, greaseless, water soluble jelly.
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    K Number
    K070692
    Device Name
    DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK
    Manufacturer
    DUKAL CORPORATION
    Date Cleared
    2007-05-30

    (78 days)

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

    DUKAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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