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Found 10 results
510(k) Data Aggregation
K Number
K062138Device 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
880.6250Why 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
K051625Device Name
BARRIER SURGICAL DRAPES
Manufacturer
MOLNLYCKE HEALTH CARE, INC.
Date Cleared
2005-07-14
(24 days)
Product Code
KKX
Regulation Number
878.4370Why 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
K000902Device Name
KLINIDRAPE REINFORCED SURGICAL GOWNS
Manufacturer
MOLNLYCKE HEALTH CARE, INC.
Date Cleared
2000-07-11
(112 days)
Product Code
FYA
Regulation Number
878.4040Why 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
K000901Device 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
878.4040Why 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
K000906Device Name
KLINIDRAPE SURGICAL DRAPES
Manufacturer
MOLNLYCKE HEALTH CARE, INC.
Date Cleared
2000-06-23
(94 days)
Product Code
KKX
Regulation Number
878.4370Why 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
K984371Device Name
MEPITEL NON ADHERENT SILICONE DRESSING
Manufacturer
MOLNLYCKE HEALTH CARE, INC.
Date Cleared
1999-03-03
(86 days)
Product Code
MGP
Regulation Number
N/AWhy 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
K984370Device Name
HYPERGEL 20% HYPERTONIC SALINE GEL
Manufacturer
MOLNLYCKE HEALTH CARE, INC.
Date Cleared
1999-03-01
(84 days)
Product Code
MGQ
Regulation Number
N/AWhy 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
K984368Device 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/AWhy 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
K983554Device Name
ALLDRESS, ABSORBENT FILM DRESSING
Manufacturer
MOLNLYCKE HEALTH CARE, INC.
Date Cleared
1998-11-10
(28 days)
Product Code
KMF
Regulation Number
880.5090Why 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
K983184Device Name
MEPILEX
Manufacturer
MOLNLYCKE HEALTH CARE, INC.
Date Cleared
1998-10-28
(47 days)
Product Code
MGP
Regulation Number
N/AWhy 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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