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510(k) Data Aggregation

    K Number
    K172835
    Device Name
    GRI-Alleset Veress Needle
    Manufacturer
    GRI Medical and Electronic Technology Co., Ltd.
    Date Cleared
    2018-06-11

    (265 days)

    Product Code
    HIF
    Regulation Number
    884.1730
    Why did this record match?
    Applicant Name (Manufacturer) :

    **GRI Medical **and Electronic Technology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GRI-Alleset Veress Needle is a disposable, single-use, sterile device intended to be used in minimally-invasive abdominal procedures for the establishment of pneumoperitoneum.
    Device Description
    The GRI-Alleset Veress Needle is a disposable, single-use, sterile surgical instrument used during minimally invasive surgery for the establishment of peritoneum of the abdominal cavity prior to abdominal surgery. The device is comprised of a 14 gauge stainless steel needle (120mm and 150mm in length) which is attached to a plastic handle that contains a stopcock with a luer lock connector. The spring-loaded, blunt stylet extends beyond the needle tip and retracts as the needle is pushed through the abdominal tissue; it automatically advances forward once the peritoneum is penetrated. A red safety indicator, attached to the proximal end of the stylet, is exposed above the handle as an indication of an exposed needle tip. The device is provided sterile via ethylene oxide.
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    K Number
    K172445
    Device Name
    RoyalGuard Surgical Gown, i600, Breathable
    Manufacturer
    GRI Medical & electrical Technology Co., Ltd
    Date Cleared
    2017-12-08

    (116 days)

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

    **GRI Medical **& electrical Technology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RoyalGuard Surgical Gown, i600, Breathable is a single use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. The RoyalGuard Surgical Gown, i600, Breathable has been tested as Level 4 in the critical zones per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.
    Device Description
    The RoyalGuard Surgical Gown, i600, Breathable (i90-61xx-S1) consists of a tri-laminate fabric Breathable Viral Barrier (BVB) including an outer and inner layer of spunbond polyolefin fabric with a middle layer of breathable monolithic film in the gown front body and gown sleeves. The gown sleeves critical zones also consist of an additional layer of Film Reinforcement Bi-laminate material, including a layer of spunbond and a layer of film. The gown back panels are comprised of a single layer of SMS (polyolefin nonwoven). The RoyalGuard Surgical Gown, i600, Breathable (i90-61xx-S1) is provided with neck binder, hook and loop tabs, belt ties, removable transfer accessory, and cuffs. There are eight regular sizes and two special sizes (A-frame) available for each design in both sterile and non-sterile packaging configurations, including: S, M, L, XL, XXL, L-XLONG, XXL-XLONG, A-frame L-XLONG, Aframe XL-XLONG. The two special sizes (A-frame L-XLONG, A-frame XL-XLONG) have much wider bottom that are designed for sitting procedures. The RoyalGuard Surgical Gown, i600, Breathable (i90-61xx-51) has been tested according to AAMI PB70:2012 and met the AAMI Level 4 liquid barrier performance requirements. It is constructed with or without thumb-hooks in cuffs. The addition of thumb-hooks does not impact the performance of the gown in accordance with AAMI PB70 requirement.
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    K Number
    K172712
    Device Name
    gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler
    Manufacturer
    GRI Medical & Electronic Technology Co, Ltd
    Date Cleared
    2017-11-06

    (59 days)

    Product Code
    FMK
    Regulation Number
    878.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    **GRI Medical **& Electronic Technology Co, Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The gentleheel® devices are heel incision devices for blood sampling in newborns, premature and low birth weight infants, and toddlers. The gentleheel has a sharps prevention feature to protect the user from a sharps injury.
    Device Description
    The gentleheel is designed to be an easy to use, safe, one handed heel incision device for acquiring blood samples from the heels of newborns. The welded plastic housing is designed to prevent accidental exposure to the blade, to be ergonomic for improved handling, and compatible with an infant's foot. The user is instructed to remove the trigger lock. When the gentleheel is placed against the infant's heel and the user presses the trigger mechanism it automatically makes the incision by starting the blade in a continuous motion from inside the housing, into the infant's heel, and then back within the housing. The trigger mechanism is no longer functional and the blade remains inside the housing through disposal. The entire device is discarded in a sharps container after use. The gentleheel comes in models for Newborn, Preemie, Micro-Preemie and Toddler. The models are differentiated by the styles and colors of the housing (see definitions below).
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    K Number
    K163191
    Device Name
    ComfortGuard Surgical Gown, i600, Film Reinforced
    Manufacturer
    GRI MEDICAL & ELECTRICAL TECHNOLOGY CO., LTD.
    Date Cleared
    2017-02-27

    (105 days)

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

    **GRI MEDICAL **& ELECTRICAL TECHNOLOGY CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ComfortGuard Surgical Gown, i600, Film Reinforced is a single use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
    Device Description
    The ComfortGuard Surgical Gown, i600, Film Reinforced (i90-82xx-S1) consists of a multi-layer in the critical zones (SMS & Film Lamination), single layer of SMS (polyolefin nonwoven) in the noncritical zones in the body and sleeve, single layer of SMS (polyolefin nonwoven) in the back panel with a lower basis weight SMS. The ComfortGuard Surgical Gown, i600, Film Reinforced (i90-82xx-S1) is provided with neck binder, hook and loop tabs, belt ties, removable transfer accessory, and cuffs. There are eight regular sizes and two special sizes (A-frame) available for each design in both sterile and nonsterile packaging configurations, including: S, M, L, XL, XXL, L-XLONG, XXL-XLONG, XXL-XLONG, Aframe L-XLONG, A-frame XL-XLONG. The two special sizes (A-frame L-XLONG, A-frame XL-XLONG) have much wider bottom that are designed for sitting procedures. And the reinforcement still covers the critical zone as in the other product codes. The ComfortGuard Surgical Gown, i600, Film Reinforced (i90-82xx-S1) has been tested according to AAMI PB70:2012 and met the AAMI Level 4 liquid barrier performance requirements. It is constructed with or without thumb-hooks in cuffs, with pleats in the back panels, with a lower basis weight SMS in the back panel. The addition of thumb-hooks, back pleats, and the use of a lighter basis weight material in the back panels does not impact the performance of the gown in accordance with AAMI PB70 requirement.
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    K Number
    K162442
    Device Name
    ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500
    Manufacturer
    GRI MEDICAL & ELECTRICAL TECHNOLOGY CO., LTD.
    Date Cleared
    2016-12-12

    (103 days)

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

    **GRI MEDICAL **& ELECTRICAL TECHNOLOGY CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ComfortGuard Plus Surgical Gown, i500 are single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. ComfortGuard Plus Surgical Gown, i500 have been tested and are classified as Level 3 in the critical zones per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. ComfortGuard Surgical Gown, i500 are single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. ComfortGuard Surgical Gown, i500 have been tested and are classified as Level 3 in the critical zones per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.
    Device Description
    The ComfortGuard Plus Surgical Gown, i500 (i90-70xx-S1) is comprised of a single layer of polyolefin nonwoven SMS fabric throughout the entire gown, with no additional reinforcement. The ComfortGuard Surgical Gown, i500 (i90-80xx-S1) is comprised of a single layer of polyolefin nonwoven SMS fabric throughout the entire gown, with no additional reinforcement. Both groups of surgical gowns are provided with neck binder, hook and loop tabs, belt ties, removable transfer accessory, and cuffs. There are eight sizes available for each design in both sterile and non-sterile packaging configurations, including: S, M, L, XL, XXL, L-XLONG, XL-XLONG, and XXL-XLONG, see Intended use/Indication for use. Both groups of surgical gowns have been tested according to AAMI PB70:2012 and met the AAMI Level 3 liquid barrier performance requirements. They are constructed with or without thumbhooks in cuffs, with pleats in the back panels, with a lower basis weight SMS in the back panel. The addition of thumb-hooks, back pleats, and the use of a lighter basis weight material in the back panels does not impact the performance of the gown in accordance with AAMI PB70 requirement.
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    K Number
    K111458
    Device Name
    GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS
    Manufacturer
    GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD.
    Date Cleared
    2011-12-01

    (189 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    **GRI MEDICAL **& ELECTRONIC TECHNOLOGY CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GRI single use drapes (both sterile and non-sterile) are made of natural or synthetic material intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. Non-sterile GRI surgical drapes are sold, in bulk as single use items, to repackager/relabeler establishments for further packaging and ethylene oxide (EtO) sterilization. GRI single use surgical equipment covers (both sterile and non-sterile) are protective barrier covers intended to be used to cover surgical equipment and provide a protective barrier for that equipment. Non-sterile GRI surgical equipment covers are sold, in bulk as single use items, to repackager/relabeler establishments for further packaging and ethylene oxide (EtO) sterilization.
    Device Description
    GRI's single use drapes and surgical equipment covers with AAMI Liquid Barrier Level 3 claim are constructed with various base sheet fabric and reinforcement fabric types, provided in various sizes and shapes, and may contain fluid collection pouches or clear film panels as components. The base sheet fabric is a three layer laminate comprised of polypropylene spunbond/polypropylene mettblown/polypropylene spunbond. Layers are thermally embossed together producing a single layer with various basis weights. Fabric is topically treated to enhance water repellency and to assure static dissipation. The drape reinforcement fabrics are constructed of various configurations of spunbond, meltblown and film. The reinforcement materials are spunbond/film laminate. The primary component of these materials is polypropylene with surfactant and blue pigment.
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    K Number
    K102652
    Device Name
    NON REINFORCED SURGICAL GOWNS, FILM REINFORCED SURGICAL GOWNS, FABRIC REINFORCED SURGICAL GOWNS
    Manufacturer
    GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD.
    Date Cleared
    2011-02-03

    (142 days)

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

    **GRI MEDICAL **& ELECTRONIC TECHNOLOGY CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GRI's Non Reinforced, Film Reinforced, and Fabric Reinforced Surgical Gowns are sterile or non-sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
    Device Description
    GRI's Non Reinforced, Film Reinforced and Fabric Reinforced Surgical Gowns are made from SMS fabrics and polypropylene/polyethylene protective reinforcement to provide user protection in surgical settings. The gowns are available in various designs and combinations of materials, sizes, and reinforcement configurations. The Non Reinforced Surgical Gowns meet the requirements of AAMI Level 2 liquid barrier requirements. The Fabric-Reinforced Surgical Gowns meet the requirements of AAMI Level 3 liquid barrier requirements. The Film-Reinforced Surgical Gowns meet the requirements of AAMI Level 3 liquid barrier requirements.
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