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510(k) Data Aggregation

    K Number
    K251967

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-03-18

    (265 days)

    Product Code
    Regulation Number
    878.4040
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    510k Summary Text (Full-text Search) :

    Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor

    Regulation Number: 21 CFR 878.4040
    FXX | FXX | Same |
    | FDA Classification | Class II | Class II | Same |
    | Regulation Number | 21 CFR 878.4040
    | 21 CFR 878.4040 | Same |
    | Common Name | Surgical Mask | Surgical Mask | Same |

    Page 6

    HALYARD

    FXX | FXX | Same |
    | FDA Classification | Class II | Class II | Same |
    | Regulation Number | 21 CFR 878.4040
    | 21 CFR 878.4040 | Same |
    | Common Name | Surgical Mask | Surgical Mask | Same |

    **O&M Halyard, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask(s) 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 of the wearer to blood and body fluids. These are single use, disposable device(s), provided nonsterile.

    Device Description

    The HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, and HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor, are four-layer masks, constructed of well-known non-woven materials. Both masks are provided with earloops and a malleable nosepiece, placed within the bindings for comfort, to conform to the curvature of the wearer's nose.

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    K Number
    K252534

    Validate with FDA (Live)

    Date Cleared
    2026-03-03

    (203 days)

    Product Code
    Regulation Number
    878.4040
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    Why did this record match?
    510k Summary Text (Full-text Search) :

    China

    Re: K252534
    Trade/Device Name: Surgical Face Mask (Ear mount)
    Regulation Number: 21 CFR 878.4040

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Surgical Face Masks 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(s), provided non-sterile.

    Device Description

    Not Found

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    K Number
    K251860

    Validate with FDA (Live)

    Date Cleared
    2026-02-26

    (254 days)

    Product Code
    Regulation Number
    878.4040
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    510k Summary Text (Full-text Search) :

    Taiwan

    Re: K251860
    Trade/Device Name: Copioumed AAMI 3 Surgical Gown
    Regulation Number: 21 CFR 878.4040
    Taiwan

    Re: K251860
    Trade/Device Name: Copioumed AAMI 3 Surgical Gown
    Regulation Number: 21 CFR 878.4040
    Proprietary Name: Copioumed AAMI 3 Surgical GownProduct Code: FYARegulation Number: 21 CFR 878.4040
    Name: Cardinal Health™ Non-Reinforced Surgical GownProduct Code: FYARegulation Number: 21 CFR 878.4040

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Copioumed AAMI 3 Surgical Gown is intended to be worn by operating room personnel during surgical procedures to protect both surgical patient and the operating room personnel from the transfer of microorganisms, body fluids, and particulate materials. The gown is single-use, disposable, and provided sterile, and is classified as AAMI Level 3.

    Device Description

    Copioumed AAMI 3 Surgical Gown provides protection with the materials of SMS. Copioumed AAMI 3 Surgical Gown has comfort and breathability and for a better fit on the user. The neck design of Copioumed Surgical Gown is adjustable and closes with a Velcro. Copioumed Surgical Gown is available in several sizes and lengths with two models (standard performance and high standard).

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    K Number
    K253398

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-02-19

    (142 days)

    Product Code
    Regulation Number
    878.4040
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    510k Summary Text (Full-text Search) :

    Trade/Device Name: Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)
    Regulation Number: 21 CFR 878.4040

    • II
    • Classification Name: Mask, Surgical
    • Product Code: FXX
    • Regulation No.: 21 CFR 878.4040
    • II
    • Classification Name: Mask, Surgical
    • Product Code: FXX
    • Regulation No.: 21 CFR 878.4040
      Surgical Mask | Similar |
      | FDA Product Code | FXX | FXX | Same |
      | Classification | Class II, 21CFR 878.4040
      | Class II, 21CFR 878.4040 | Same |
      | Model | EFX3PLBLKMSK300 | EFX3PLYSMSK | Similar |
      | Indications
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This single use surgical mask EFX3PLBLKMSK300 is intended to be worn to protect both the patient and health care 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, disposal device, provided non-sterile.

    Device Description

    The device is a flat pleated type of mask the outer layer being black and the inner layer being black, utilizing ear loops to secure the mask in place, and a nose bridge is also incorporated for a proper fit around the nose. The device number is EFX3PLBLKMSK300.
    The device is manufactured with three layers, the inner and outer layers are made of spun bond polypropylene, and the middle layer is made of melt-blown polypropylene filter material. The model EFX3PLBLKMSK300 device is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of polypropylene and spandex. The nose bridge contained within the device is placed between the layers of the surgical mask to allow the user to form the surgical mask properly around their nose. The nose bridge is made up of galvanized wire coated with polyethylene.

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    K Number
    K252301

    Validate with FDA (Live)

    Date Cleared
    2026-02-04

    (195 days)

    Product Code
    Regulation Number
    878.4040
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    510k Summary Text (Full-text Search) :

    K252301**
    Trade/Device Name: Henan Yadu Level 4 Surgical Gowns (Reinforced)
    Regulation Number: 21 CFR 878.4040
    Information

    Trade Name of Device: Henan Yadu Level 4 Surgical Gown (Reinforced)
    Regulation Number: 878.4040
    Information

    510k Number: K182172
    Trade Name of Device: Surgical Apparel
    Regulation Number: 878.4040
    Medline Level 4 Surgical Gown (Aurora) | N/A |
    | Product code | FYA | FYA | Same |
    | Regulation Number | 878.4040
    | 878.4040 | Same |
    | Manufacturer | YADU Medical (Henan) Co., Ltd. | Medline Industries, Inc. | N/A

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Henan Yadu Level 4 Surgical Gown (Reinforced) are sterile, single-use surgical apparel intended to be used by operating room personnel during surgical operations and other invasive examinations to provide a liquid and microbial barrier for patients and medical staff.

    These products meet the Level 4 liquid barrier performance requirements of ANSI/AAMI PB70:2022 "Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities."

    Device Description

    Henan Yadu Level 4 Surgical Gowns (Reinforced) are sterile, single-use surgical apparel intended to be worn by healthcare professionals during surgical procedures to provide barrier protection against the transfer of microorganisms, body fluids, and particulate matter in critical surgical zones for both patients and healthcare personnel.

    These products meet the Level 4 liquid barrier performance requirements of ANSI/AAMI PB70:2022 "Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.

    Gowns have six different sizes: Small (S), Medium (M), Large (L), Extra Large (XL), Extra Extra Large (XXL), Extra extra extra Large (XXXL).

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    K Number
    K252830

    Validate with FDA (Live)

    Date Cleared
    2026-01-12

    (129 days)

    Product Code
    Regulation Number
    878.4040
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    510k Summary Text (Full-text Search) :

    K252830**
    Trade/Device Name: Disposable Surgical Face Mask (3P00B, C2900)
    Regulation Number: 21 CFR 878.4040
    Surgical Face Mask
    Classification: Class II
    Product code: FXX
    Regulation Number: 21 CFR 878.4040
    19 Level 2 and Level 3 | Similar |
    | Product Code | FXX | FXX | Same |
    | Regulation Number | 21 CFR 878.4040
    | 21 CFR 878.4040 | Same |
    | Indications For Use | The Disposable Surgical Face Masks are intended to

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transferring of microorganisms, body fluids and particulate material. These surgical 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(s), provided non-sterile.

    Device Description

    The subject Disposable Surgical Face Masks has two models, that is Model: 3P00B, ASTM F2100 Level 2 and Model: C2900, ASTM F2100 Level 3.

    The Disposable Surgical Face Masks (Model: 3P00B, Level 2) are three-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer, middle layer and outer layer. The colorant is blue master batch. The inner layer and outer layer of 3P00B mask are made of spun-bond non-woven fabric, the middle layer is made of Polyethylene Melt-blown non-woven fabric.

    The Disposable Surgical Face Masks (Model: C2900, Level 3) are four-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer, second layer, filtration layer and outer layer. The colorant is blue master batch.

    The inner layer and outer layer of C2900 are made of spun-bonded non-woven fabric, the second layer is made of Polyethylene PE film, the filtration layer is made of Polyethylene Melt-blown non-woven fabric.

    The ear loops of both models are held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loops are made with Polyester and spandex. The aluminum nose piece in the layers of face mask is to allow the user to form the mask around their nose.

    The Disposable Surgical Face Masks of both models are sold non-sterile and are intended to be single use, disposable devices.

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    K Number
    K252650

    Validate with FDA (Live)

    Date Cleared
    2026-01-05

    (136 days)

    Product Code
    Regulation Number
    878.4040
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    510k Summary Text (Full-text Search) :

    China

    Re: K252650
    Trade/Device Name: Disposable Medical Face Mask
    Regulation Number: 21 CFR 878.4040
    Surgical Face Mask
    Classification: Class II
    Product code: FXX
    Regulation Number: 21 CFR 878.4040
    | K252650 | K202903 | Different |
    | Product Code | FXX | FXX | Same |
    | Regulation Number | 21 CFR 878.4040
    | 21 CFR 878.4040 | Same |
    | Regulatory Class | Class Ⅱ | Class Ⅱ | Same |

    Page 7

    3 / 5

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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Disposable Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Disposable Medical Face Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

    Device Description

    The Disposable Medical Face Mask is single use, three-layer, 3-pleated or 4-pleated flat-folded masks with nose piece and ear loops or ties. The masks will be provided in blue or black color with option for a visor. The colorant is polypropylene (PP) master batch.

    The body of the mask is composed of three layers: the inner and outer layers are made of spun-bond polypropylene, the 2nd layer is made of melt blown polypropylene. The only difference between Level 1, Level 2, and Level 3 masks is the material density in the middle layer. The nose piece is made of Iron wire covered with polypropylene plastic, ear loop is made of elastic band, the ties are made of spun-bond polypropylene, and the visor is made of polyethylene terephthalate (PET).

    Each mask contains ear loops or ties to secure the mask over the user's face and mouth with a bendable nose piece to firmly fit over the nose. This device is not made with natural rubber latex.

    The disposable medical face masks are sold non-sterile and are intended to be single use, disposable devices.

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    K Number
    K243342

    Validate with FDA (Live)

    Date Cleared
    2025-12-22

    (423 days)

    Product Code
    Regulation Number
    878.4040
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    510k Summary Text (Full-text Search) :

    South

    Re: K243342/S001
    Trade/Device Name: KP Protective Face Mask
    Regulation Number: 21 CFR 878.4040
    Common Name:** Surgical Mask
    Classification Name: Surgical Apparel
    Regulation Number: 21 CFR 878.4040

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The KP Protective Face Mask is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from transfer of microorganisms, body fluids, and particulate material.

    Device Description

    The KP Protective Face Mask is a non-sterile, single-use surgical mask intended to cover the user's nose and mouth, providing a physical barrier to fluids, microorganisms, and particulate matter.

    The mask consists of three nonwoven polypropylene layers, including:

    • Outer layer: Spunbond non-woven
    • Filter layer: Melt-blown polypropylene
    • Inner comfort layer: Spunbond non-woven
    • Nose wire: Polypropylene-clad adjustable wire
    • Attachment: Elastic earloops (A mixture of nylon and polyurethane)

    The mask is white, flat-fold style, supplied non-sterile, and packaged in standard pouches.

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    K Number
    K252940

    Validate with FDA (Live)

    Date Cleared
    2025-12-16

    (92 days)

    Product Code
    Regulation Number
    878.4040
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    Why did this record match?
    510k Summary Text (Full-text Search) :

    **
    Trade/Device Name: VR® Personal Protective Level 3 Gown (VR Gowns)
    Regulation Number: 21 CFR 878.4040
    **
    Trade/Device Name: VR® Personal Protective Level 3 Gown (VR Gowns)
    Regulation Number: 21 CFR 878.4040

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The VR® Personal Protective Level 3 Gown is intended to protect healthcare patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. The VR® Personal Protective Level 3 Gown is a single use, disposable gown provided non-sterile. The back of the VR Gown is open and non-protective. The VR Gown is not intended for use in the operating room.

    Device Description

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    K Number
    K252941

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-12-11

    (87 days)

    Product Code
    Regulation Number
    878.4040
    Age Range
    18 - 100
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    510k Summary Text (Full-text Search) :

    HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops
    Regulation Number: 21 CFR 878.4040
    FXX | Same |
    | FDA Classification | Class II | Class II | Same |
    | Regulation Number | 21 CFR 878.4040
    | 21 CFR 878.4040 | Same |
    | Common Name | Surgical Mask | Surgical Mask | Same |
    | **Indication

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The HALYARD* Adult Face Mask(s) 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 of the wearer to blood and body fluids. These are single use, disposable device(s), provided non-sterile.

    Device Description

    The HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops, is a three-layer mask, constructed of well-known non-woven materials. The mask is provided with earloops and a malleable nosepiece, placed within the bindings for comfort, to conform to the curvature of the wearer's nose.

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