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510(k) Data Aggregation

    K Number
    K221753
    Device Name
    Kangbeier Child Surgical Mask
    Manufacturer
    Xinxiang Kangbeier Medical Technology Co., Ltd.
    Date Cleared
    2023-12-21

    (553 days)

    Product Code
    OXZ
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    OXZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kangbeier Child Surgical Mask is intended to be worn by the patient (ages 5-10) to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms and particulate materials. The Kangbeier Child Surgical Mask is a single use, disposable device, provided non-sterile. This Face Mask is recommended for use in a healthcare setting with appropriate adult supervision.
    Device Description
    The Kangbeier Child Surgical Mask is composed of three layers of materials and pleated to form the mask. The inner layer is composed of spun-bond nonwoven polypropylene, the middle layer is meltblown polypropylene filter material, and the outer layer is spunbond nonwoven polypropylenen. The color on the outer layer is consists of Phthalocyanine Blue and PE wax and PP. Masks are held in place on wearer with elastic spun-bond polypropylene earloop and contain a malleable aluminum nosepiece strip. The Kangbeier Child Surgical Mask is appropriately sized to the smaller faces of children across a diverse population. The Kangbeier Child Surgical Mask is a single use, disposable device, provided nonsterile with no shelf-life. Storage conditions will not affect device safety of effectiveness. All of the materials used in this device are typical materials commonly used in the construction of Surgical Masks and are being used in current legally marketed devices.
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    K Number
    K213427
    Device Name
    PRIMED Pediatric Facemask
    Manufacturer
    PRIMED Medical Products Inc.
    Date Cleared
    2022-11-22

    (397 days)

    Product Code
    OXZ
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    OXZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PRIMED level 1 Pediatric Facemask is a single use, disposable device that is intended to be used by patient/child 4 to 12 years old in healthcare setting under an adult supervision to provide a barrier for the respiratory tract from microorganisms, body fluids and particulate material.
    Device Description
    The PRIMED level 1 Pediatric Facemask is a single use, disposable device intended to be used by patient/child 4 to 12 years old in healthcare setting under an adult supervision to prevent the transmission of microorganism. PRIMED Pediatric Mask (PG4-1680) is composed of 4 layers of non-woven material bounded together and pleated to form a mask. This mask is appropriately sized to the smaller faces of children between ages of 4 to 12 years old. PRIMED pediatric mask meets the requirements of ASTM F2100 for level 1 procedure mask while providing a lower differential pressure this mask is single use, disposable and is provided non-sterile. All of materials used in this device are typical materials commonly used in the construction of legally marketed surgical/ procedure masks with a safe history of use. The mask is not made with natural rubber latex.
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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?
    Product Code :

    OXZ

    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
    K201514
    Device Name
    Child Face Mask
    Manufacturer
    Shandong Shengquan New Material Co., Ltd.
    Date Cleared
    2021-10-10

    (489 days)

    Product Code
    OXZ
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    OXZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Children Face Mask is a single use, disposable device that is intended to be worn by children (recommended ages 5-10) to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms, body fluid and particulate materials. The mask is specifically for child or pediatric patients to provide protection for the respiratory tract. This face mask is recommended for use in a healthcare setting with appropriate adult supervision.
    Device Description
    Children Face Mask is a single use, disposable device that is intended to be worn by children (recommended ages 5-10) to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms, body fluid and particulate materials.
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    K Number
    K202831
    Device Name
    The iMask Child's Face Mask
    Manufacturer
    Pac-Dent, Inc.
    Date Cleared
    2021-08-26

    (335 days)

    Product Code
    OXZ
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    OXZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iMask Child's Face Mask is intended to be worn by the patient/child (recommended ages 4-12) to provide protection for the respiratory tract. This is a single use, disposable device, provided non-sterile. This Face Mask is recommended for use in a healthcare setting with appropriate adult supervision.
    Device Description
    Not Found
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    K Number
    K190308
    Device Name
    Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1)
    Manufacturer
    AMD Medicom, Inc.
    Date Cleared
    2019-09-17

    (217 days)

    Product Code
    OXZ
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    OXZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Mask (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Mask, Medicom SafeMask Premier Procedure Earloop Face Mask (ASTM Level 1) and Medicom SafeMask Premier Pediatic Procedure Earloop Face Mask are intended to be worn by the patient/ child (recommended 4-12 years of age). The face mask is to be placed on nose and mouth as a protective barrier to provide respiratory protection in procedures or situations where there is a risk of microorganism, body fluid and particulate aerosol transfer. It is a single use, non-sterile disposable device that is recommended for use in healthcare settings with appropriate adult supervision.
    Device Description
    Medicom Pediatric/Child's Face Mask is a manufactured pleated three-layer mask construction utilizing ultrasonic bonding. The patterned (ink printed) outer layer is composed of spunbound polypropylene (SBPP) material. The filter media is composed of meltblown polypropylene (MBPP). The inner is either tissue/ cellulose or a spunbound polypropylene (SBPP) layer. Bindings are composed of nonwoven polyester and earloops are made of flat elastic knitted polyester band. A malleable polypropylene nosepiece (made of plastic covered iron wire or 100% aluminum piece) is placed within the bindings for comfort and individualized fit around the wearer's nose. Medicom Pediatric/Child's Face Mask is a non-sterile single use disposable device. The device safety of effectiveness is not affected by storage conditions with no shelf life.
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    K Number
    K160100
    Device Name
    Prestige Ameritech Pediatric/Child’s Face mask
    Manufacturer
    Prestige Ameritech
    Date Cleared
    2016-10-07

    (262 days)

    Product Code
    OXZ
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    OXZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Prestige Ameritech Pediatric/Child Face Mask is intended to be worn by the patient/Child Facemask is a single use, disposable device, provided non-sterile. The Pediatric/Child Facemask is intended to be worn by the patient (ages 4-12) to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms and particulate materials. The mask is specifically for use with patients whose age or illness may prevent them from taking necessary precautions where transfer of microorganisms, body fluids, and particulates can occur.
    Device Description
    The Prestige Ameritech Pediatric/Childs Face Mask is manufactured using ultrasonic bonding, composed of three layers of materials and pleated to form the mask. The inner layer is composed of nonwoven, the middle layer is meltblown polypropylene filter material, and the outer layer is cellulose. Decorative patterns are printed with colored inks. Masks are held in place on wearer with knitted polyester/spandex elastic earloop and contain a malleable aluminum nosepiece strip. The Pediatric/Child's Face Mask is appropriately sized to the smaller faces of children across a diverse population. The Pediatric/Child's Face Mask is a single use, disposable device, provided non-sterile with no shelf-life. Storage conditions will not affect device safety of effectiveness. All of the materials used in this device are typical materials commonly used in the construction of Surgical Masks and are being used in current legally marketed devices. This product is not made with natural rubber latex.
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    K Number
    K113340
    Device Name
    KIMBERLY-CLARK CHILD'S FACEMASK
    Manufacturer
    KIMBERLY-CLARK
    Date Cleared
    2012-05-04

    (172 days)

    Product Code
    OXZ
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    OXZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kimberly-Clark Pediatric/ Child Facemask, is intended to be worn by the patient/child (recommended ages 4-12) to provide protection for the respiratory tract. It is a single use, disposable device that is provided non-sterile. This Face Mask is recommended for use in a healthcare setting with appropriate adult supervision.
    Device Description
    The Kimberly-Clark Pediatric/ Child Facemask is a three layer mask, constructed of nonwoven polyester blends and polypropylene materials. Bindings are nonwoven polyester and earloops are knitted polyester/lycra. A malleable nosepiece is placed within the bindings for comfort and individualized fit around the wearer's nose. The Pediatric/ Child Facemask is appropriately sized to the smaller faces of children across a diverse population. The Pediatric/ Child Facemask is a single use, disposable device, provided non-sterile.
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    K Number
    K103150
    Device Name
    KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK
    Manufacturer
    KIMBERLY-CLARK
    Date Cleared
    2011-09-23

    (332 days)

    Product Code
    OXZ
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    OXZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kimberly-Clark Pediatric/ Child Facemask, is intended to be worn by the patient/child (recommended ages 5-12) to provide protection for the respiratory tract. It is a single use, disposable device that is provided non-sterile. This Face Mask is recommended for use in a healthcare setting with appropriate adult supervision.
    Device Description
    The Kimberly-Clark Pediatric/ Child Facemask is a three layer mask, constructed of nonwoven polyester blends and polypropylene materials. Bindings are nonwoven polyester and earloops are knitted polyester/lycra. A malleable nosepiece is placed within the bindings for comfort and individualized fit around the wearer's nose. The Pediatric/ Child Facemask is appropriately sized to the smaller faces of children across a diverse population. The Pediatric/ Child Facemask is a single use, disposable device, provided non-sterile.
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