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510(k) Data Aggregation

    K Number
    K230645
    Device Name
    BeneHold™ Surgical Incise Drape with CHG antimicrobial II
    Manufacturer
    Avery Dennison Medical Ltd.
    Date Cleared
    2023-10-25

    (231 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Product Code :

    KKX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BeneHold™ Surgical Incise Drape with CHG antimicrobial II is indicated for use as an incise drape with continuous antimicrobial activity (in vitro) from 30 minutes through 4 hours of use against the following organisms: S. aureus, S. epidermidis, E. coli, P. aeruginosa, E. aerogenes, and C. albicans. In vitro testing on the subject drape has also shown continuous antimicrobial activity from 30 minutes through 2.5 hours against E. faecalis and F. oxysporum. It is intended for external use only. Correlation between in vitro results and any clinical event has not been tested.
    Device Description
    Not Found
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    K Number
    K222578
    Device Name
    3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)
    Manufacturer
    3M Company
    Date Cleared
    2023-05-18

    (266 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Product Code :

    KKX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) is indicated for use as an incise drape with continuous antibacterial activity based on in vitro time kill data out to 90 minutes. It is intended for external use only.
    Device Description
    3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) is a sterile adhesive film that is applied pre-operatively to skin. It adheres and conforms to body contours, providing a sterile surface on top of the skin prior to surgery. The surgeon incises through the adhesive film and skin, ensuring a sterile film barrier all the way to the edge of the incision. The Chlorhexidine Gluconate (CHG) contained in the adhesive provides antibacterial activity to help reduce the risk of bacterial contamination in the surgical wound. The drape consists of a transparent, conformable, barrier film coated with an acrylic adhesive containing 2% w/w CHG. The adhesive drape is delivered on a release liner that is discarded after application.
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    K Number
    K202208
    Device Name
    BeneHold Surgical Incise Drape with CHG antimicrobial
    Manufacturer
    Avery Dennison Belgie BVBA
    Date Cleared
    2021-07-30

    (358 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Product Code :

    KKX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BeneHold™ Surgical Incise Drape with CHG is indicated for use as an incise drape with continuous antibacterial activity (in vitro) from 2.5 to 4 hours against the following organisms; S. epidermidis, E. faecalis, E. coli, P. aeruginosa and E. aerogenes. It is intended for external use only. Correlation between in vitro results and any clinical event has not been tested.
    Device Description
    Not Found
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    K Number
    K200238
    Device Name
    ControlRad Sterile Cover
    Manufacturer
    ControlRad, Inc
    Date Cleared
    2020-04-26

    (86 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Product Code :

    KKX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ControlRad Sterile Cover is a single use sterile equipment cover intended for use by professionals in a sterile clinical setting to cover the ControlRad Trace Tablet and create a sterile barrier between the rest of the sterile field to prevent contamination during various procedures.
    Device Description
    The ControlRad Sterile Cover is a terminally sterilized device intended to cover the ControlRad tablet in order to operate a ControlRad tablet in a sterile environment.
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    K Number
    K163556
    Device Name
    MediClear PreOp
    Manufacturer
    COVALON TECHNOLOGIES, INC.
    Date Cleared
    2017-09-14

    (269 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Product Code :

    KKX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MediClear™ PreOp is indicated for use as a pre-operative (incision/insertion) drape that provides continuous antimicrobial activity to reduce the risk of contamination of the skin site by acting as an external barrier to microbial and other contamination. MediClear™ PreOp can be left on the preoperative incision site for up to 7 days. MediClear™ PreOp is intended to be used on intact skin and for external use only.
    Device Description
    MediClear™ PreOp consists of a clear polyurethane film coated with an antimicrobial silicone adhesive containing 3% w/w chlorhexidine and 0.5% w/w silver salts and is intended to cover and protect skin from the risk of contamination prior to an invasive procedure (i.e. incision or insertion). The chlorhexidine and silver contained in the adhesive provides continuous antimicrobial activity while the polyurethane barrier film acts as a protective patient covering to isolate a procedural site from microbial and other contamination. MediClear™ PreOp provides an effective physical barrier against external contamination including fluids, bacteria, and yeast. In vitro testing* demonstrates that the chlorhexidine and silver incorporated within the silicone adhesive provides a rapid bactericidal and fungicidal effect against microorganisms including Staphylococcus aureus (MRSA), Staphylococcus epidermidis, Enterococcus faecalis (VRE), Klebsiella pneumoniae, Pseudomonas aeruginosa, Enterobacter cloacae, Candida albicans, and Candida tropicalis averaging a 99.9% reduction at 10 minutes and a 99.99% reduction at 30 minutes, and prevents their re-growth for up to 7 days during wear. * In vitro effectiveness does not predict clinical performance. MediClear™ PreOp is a breathable, transparent, self-adhesive silicone film that conforms to the contours of the body.
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    K Number
    K133080
    Device Name
    Plus Surgical Drapes (EO Sterilized), PMDB-XXX
    Manufacturer
    FOSHAN NANHAI PLUS MEDICAL CO., LTD.
    Date Cleared
    2015-06-24

    (632 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Product Code :

    KKX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Surgical Drapes (EO Sterilized) is a single use product used as a protective barrier for patient, such as to isolate a site of surgical incision from microbial and other contamination.
    Device Description
    Not Found
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    K Number
    K141324
    Device Name
    HONGYU DISPOSABLE SURGICAL DRAPES
    Manufacturer
    WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD
    Date Cleared
    2015-04-14

    (329 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Product Code :

    KKX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HONGYU Disposable Surgical Drapes are devices made of synthetic material intended to be used as a protective patient covering to isolate a site of surgical incision from microbial and other contamination. The drape is sterilized using ethylene oxide and is intended for single external use only. This drape is classified as Level 4 per AAMI Standard PB70 liquid barrier performance and classification of protective apparel and drapes intended for use in health-care facilities. Models C-section Drape, Arthroscopy Drape, Bladder Drape, Split (U) Drape, Arm (Wrist) Drape, Miscellaneous Drape, Abdominal Drape, Shoulder Drape, Lithotomy Drape, Neck Drape, Simple Drape, Simple Drape, Extremity Drape, Universal Drape, Head Drape, Craniotomy Drape, Buttock Drape, ENT Drape, ENT Drape, Pediatric Laparotomy Drape, Ophthalmic Drape, Angiography Drape and Articulation Drape.
    Device Description
    HONGYU Disposable Surgical Drapes are devices made of synthetic material intended to be used as a protective patient covering to isolate a site of surgical incision from microbial and other contamination. The drape is sterilized using ethylene oxide and is intended for single external use only. This drape is classified as Level 4 per AAMI Standard PB70 liquid barrier performance and classification of protective apparel and drapes intended for use in health-care facilities. HONGYU Disposable Surgery Drapes offer a variety of surgery drapes (23 types), including C-section Drape, Arthroscopy Drape, Bladder Drape, Split (U) Drape, Arm (Wrist) Drape, Miscellaneous Drape, Abdominal Drape, Shoulder Drape, Lithotomy Drape, Neck Drape, Fenestrated Drape, Simple Drape, Extremity Drape, Universal Drape, Head Drape, Craniotomy Drape, Buttock Drape, Dental Drape, ENT Drape, Pediatric Laparotomy Drape, Ophthalmic Drape, Angiography Drape and Articulation Drape. The HONGYU Disposable Surgery Drapes have a basic drape. Additionally, each of the drapes has different drape components according to the intended clinical surgery sites, such as the reinforcement, fenestration, single-coating/ double-coating medical tape. PE film and Velcro-style line holders/ tube holders.
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    K Number
    K140195
    Device Name
    SURGICAL DRAPE
    Manufacturer
    GRIFFITH-LUCAS LLC
    Date Cleared
    2014-09-10

    (226 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Product Code :

    KKX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Surgical Drape is intended for external use only and is used as a protective patient covering, such as to isolate a site of surgical incisions from microbial and other contamination. They are provided sterile using ethylene oxide.
    Device Description
    Surgical drapes are intended to provide protection from microbial and other contamination. The Lucas surgical drapes described in this submission are one-piece, single use disposable sheets designed to provide an absorbent sterile barrier during surgical procedures. The drapes cover the patient and are made of an absorbent nonwoven fabric backed with a protective film that stops fluid strike-through. There are various sizes to meet the surgeon's needs. In general, the surgeon delineates with proposed field of surgery and charges the nursing team with the responsibility of draping the patient suing different types of drapes, with & without fenestration. Lucas surgical drapes are made of nonwoven fabric composes of a three-layer composite comprised of a top layer, middle layer and bottom layer, they passed the industry standard tests that measure fluid and synthetic blood penetration, they are classified as a level 4 device under the AAMI PB 70 for barrier performance.
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    K Number
    K140330
    Device Name
    3M STERI-DRAPE FABRIC SURGICAL DRAPES
    Manufacturer
    3M HEALTH CARE
    Date Cleared
    2014-08-18

    (189 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Product Code :

    KKX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    3M Steri-Drape Fabric Surgical Drapes are used to create a sterile field for surgical procedures. They are provided sterile and intended for external use only. 3M Steri-Drape non-sterile fabric drapes are provided to other manufacturers for further processing using ethylene oxide. 3M provides information on compatibility with ethylene oxide processing. Non-sterile surgical drapes are sold to repackager or relabeler establishments for EtO sterilization according to ISO 11135-1:2007. Sterile surgical drapes are sold directly to end users after EtO sterilization validation to ISO 11135-1:2007.
    Device Description
    The 3M Steri-Drape Fabric Surgical Drapes are one-piece, dual layer, single use disposable drapes with an AAMI Level 4 Liquid Barrier. The drapes are made of a blue absorbent nonwoven fabric thermally bonded to a blue protective barrier film. The drapes are intended to be placed over the patient prior to surgery and are designed to provide an absorbent sterile barrier during surgical procedures and stop fluid strike-through to protect the surgical site and patient from microbial penetration. Steri-Drape Fabric Surgical Drapes are either provided sterile to end-users or non-sterile to kit manufacturers for further processing including EtO sterilization according to ISO 11135-1:2007 The drapes are provided in multiple sizes and shapes to meet the requirements of various clinical procedures. In general, the surgeon delineates the proposed field of surgery and charges the nursing team with the responsibility of draping the patient using different types of drapes. All models utilize the same material technology.
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    K Number
    K141438
    Device Name
    WHITNEY MEDICAL SOLUTIONS ESHIELD
    Manufacturer
    WHITNEY MEDICAL SOLUTIONS
    Date Cleared
    2014-08-14

    (76 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Product Code :

    KKX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Whitney Medical Solutions equipment drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting. These drapes are used to protect the equipment from contamination during various procedures.
    Device Description
    The Whitney Medical Solutions' eShield consists of polyethylene film (and an adhesive pad in some models) with tear guide tape and a zipper that allows the cover to be torn fairly straight across it. There is also a double sided tape below the zipper that is used as a redundant closure method with the cover being folded twice and sealed against it. The device is provided to the user sterile, is labeled for single use only and not intended for resterilization or reprocessing. The sterile eShield is sterilized using a validated irradiation sterilization method.
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