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510(k) Data Aggregation

    K Number
    K062138
    Device Name
    POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPRENE STERILE EXAMINATION GLOVE
    Manufacturer
    MOLNLYCKE HEALTH CARE, INC.
    Date Cleared
    2006-10-05

    (71 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    MOLNLYCKE HEALTH CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
    Device Description
    Class I sterile nitrile examination glove, powder free and meeting all requirements of ASTM D3578-99, ASTM 6124-97, and ISO 11137, Part 2, Sterilization of Health Care Products.
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    K Number
    K051625
    Device Name
    BARRIER SURGICAL DRAPES
    Manufacturer
    MOLNLYCKE HEALTH CARE, INC.
    Date Cleared
    2005-07-14

    (24 days)

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

    MOLNLYCKE HEALTH CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BARRIER® surgical drapes are intended for single use to be used as a protective patient covering, such as to isolate a site on a surgical incision from microbial and other contamination.
    Device Description
    The BARRIER® Surgical Drapes have been designed with an assortment of fabrics, films and other materials and have been on the market for a number of years, cleared under multiple 510(k) notifications. BARRIER® surgical drapes, drape components and assorted surgical drape packs have been developed for a variety of surgical procedures including: Angiography, Cardiovascular/Thoracic, ENT/Plastic Surgery, OB/Gynecology. Laparascopic. Laparotomy, Orthopaedic, Urology, Cranial, Nephroscopy, Pediatric and other general surgical procedures. BARRIER® Surgical Drapes have been designed with materials. which provide increased protection to help prevent possible exposure to bloodborne pathogens and other potentially infectious materials. The Barrier® Surgical Drapes are categorized into the following product groups: Patient Drapes, Equipment Drapes and Drape Components. All Barrier Drapes are categorized into ANSI/AAMI Level 2 or Level 4 based on material selection and construction.
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    K Number
    K000902
    Device Name
    KLINIDRAPE REINFORCED SURGICAL GOWNS
    Manufacturer
    MOLNLYCKE HEALTH CARE, INC.
    Date Cleared
    2000-07-11

    (112 days)

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

    MOLNLYCKE HEALTH CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000901
    Device Name
    KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD PROTECTION
    Manufacturer
    MOLNLYCKE HEALTH CARE, INC.
    Date Cleared
    2000-07-05

    (106 days)

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

    MOLNLYCKE HEALTH CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000906
    Device Name
    KLINIDRAPE SURGICAL DRAPES
    Manufacturer
    MOLNLYCKE HEALTH CARE, INC.
    Date Cleared
    2000-06-23

    (94 days)

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

    MOLNLYCKE HEALTH CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K984371
    Device Name
    MEPITEL NON ADHERENT SILICONE DRESSING
    Manufacturer
    MOLNLYCKE HEALTH CARE, INC.
    Date Cleared
    1999-03-03

    (86 days)

    Product Code
    MGP
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MOLNLYCKE HEALTH CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Mepitel is intended for the management of wounds in the granulation phase, especially painful wounds and wounds with newly formed delicate tissue such as pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, surgical incisions, second degree burns, skin abrasions, lacerations, partial and full thickness grafts, and skin tears.
    Device Description
    Mepitel is a sterile wound dressing which consists of three components: a medical grade silicone gel, a polyamide tricot net, and a low density polyethylene protective release liner. The dressing is delivered sterile in single packs and is available in the following sizes: 2" x 3" (5 cm x 7.5 cm); 3" x 4" (7.5 cm x 10 cm); 4" x 8" (10 cm x 18 cm); and 9" x 12" (20 cm x 30 cm).
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    K Number
    K984370
    Device Name
    HYPERGEL 20% HYPERTONIC SALINE GEL
    Manufacturer
    MOLNLYCKE HEALTH CARE, INC.
    Date Cleared
    1999-03-01

    (84 days)

    Product Code
    MGQ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MOLNLYCKE HEALTH CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hypergel provides a moist wound environment. Moist wound environment is known to support autolytic debridement. Hypergel is recommended for the softening and removal of dry necrosis in wounds such as pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, and open surgical wounds.
    Device Description
    Hypergel® 20% Hypertonic Saline Gel is a sterile solution in amorphus gel form. Hypergel is composed of water, sodium chloride, sodium hydroxide, xanthan gum, and potassium phosphate. Hypergel provides a moist wound environment. Moist wound environment is known to support autolytic debridement. Hypergel is recommended for the softening and removal of dry necrosis in wounds such as pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, and open surgical wounds. Hypergel® 20% Hypertonic Saline Gel represents a new formulation of Mölnlycke Health Care currently marketed Hypergel Protective Wound Gel product. This new formulation provides a higher viscosity. Hypergel® 20% Hypertonic Saline Gel is provided in 5 gm volumes in aluminum tubes. The tube nozzle is sealed with an aluminum foil which can be opened by employing a puncturing device integral to the inner surface of the cap. The nozzles are fitted with a poly retaining ring/collar which prevents the aluminum foil from being inadvertently punctured during manufacturing and handling.
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    K Number
    K984368
    Device Name
    NORMLGEL 0.9% ISOTONIC SALINE GEL
    Manufacturer
    MOLNLYCKE HEALTH CARE, INC.
    Date Cleared
    1999-02-22

    (77 days)

    Product Code
    MGQ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MOLNLYCKE HEALTH CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Normlyel is indicated for protecting granulating wounds and maintaining a moist wound environment in open wounds such as pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, and open surgical wounds.
    Device Description
    Normlgel® 0.9% Isotonic Saline Gel is a sterile sodium chloride solution in amorphus gel form. Normlgel is composed of water, sodium chloride, sodium hydroxide, xanthan gum, and potassium phosphate. Normigel is indicated for protecting granulating wounds and maintaining a moist wound environment in open wounds such as pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, and open surgical wounds. Normlgel® 0.9% Isotonic Saline Gel represents a new formulation of our own currently marketed Normlgel Protective Wound Gel product. This new formulation provides a higher viscosity. Normlgel® 0.9% Isotonic Saline Gel is provided in 5 gm and 15 gm volumes in aluminum tubes. The tube nozzle is sealed with an aluminum foil which can be opened by employing a puncturing device integral to the inner surface of the cap. The nozzles are fitted with a poly retaining ring/collar which prevents the aluminum foil from being inadvertently punctured during manufacturing and handling.
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    K Number
    K983554
    Device Name
    ALLDRESS, ABSORBENT FILM DRESSING
    Manufacturer
    MOLNLYCKE HEALTH CARE, INC.
    Date Cleared
    1998-11-10

    (28 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    MOLNLYCKE HEALTH CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Alldress is intended to absorb, protect, and maintain a moist environment in open and closed wounds such as; pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, surgical incisions, superficial burns, abrasions, lacerations, and skin tears.
    Device Description
    The Alldress Absorbent Film Dressing is a sterile moisture vapor permeable selfadhesive absorbent dressing. The Alldress dressing is individually sealed in medical grade paper pouches and packaged in cartons of ten (10) pouches each. The Alldress dressing is available in three sizes: 10x10cm (4" x 4"), 15x15cm (6" x 6") and 15x20cm (6" x 8").
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    K Number
    K983184
    Device Name
    MEPILEX
    Manufacturer
    MOLNLYCKE HEALTH CARE, INC.
    Date Cleared
    1998-10-28

    (47 days)

    Product Code
    MGP
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MOLNLYCKE HEALTH CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Mepilex is designed for a wide range of shallow wounds, which have low to moderate levels of exudate, e.g., leg ulcers, pressure ulcers and skin lesions.
    Device Description
    The Mepilex is a sterile, absorbent silicone-coated dressing designed for a wide range of shallow wounds, which have low to moderate levels of exudate, e.g., leg ulcers, pressure ulcers and skin lesions.
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