Search Results
Found 4 results
510(k) Data Aggregation
K Number
K111413Device Name
BIOGEL (R) INDICATOR (R) UNDERGLOVE
Manufacturer
MOLNLYCKE HEALTHCARE, US LLC
Date Cleared
2012-01-30
(255 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
MOLNLYCKE HEALTHCARE, US LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Biogel® PI Indicator® Underglove is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.
Device Description
The proposed device, the Biogel PI Indicator Underglove is manufactured of polyisoprene colored with blue pigmentation. The Biogel PI Indicator Underglove is manufactured of the exact same material and coated with the Biogel® Coating which is used on the currently cleared device that has been legally marketed by Molnlycke Health Care for many years with the addition of a surfactant.
Ask a Question
K Number
K112089Device Name
BIOGEL ORTHOPOR BROWN SURGICAL GLOVE
Manufacturer
MOLNLYCKE HEALTHCARE, US LLC
Date Cleared
2011-08-24
(34 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
MOLNLYCKE HEALTHCARE, US LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Biogel® OrthoPro® Brown Surgical Glove is a disposable device made of natural rubber latex that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.
Device Description
The proposed device, the Biogel® OrthoPro® Brown Surgical Glove is manufactured of natural rubber latex colored with brown nigmentation. The Biogel® OrthoPro® Brown Surgical Glove is manufactured of the exact same material and coated with the Biogel® Coating which is used on the currently cleared device(s) that have been legally marketed by Mölnlycke Health Care for many years with the addition of the brown colorant. The glove former design used in the manufacture of this glove allows the Biogel® OrthoPro® Brown Surgical Glove to provide the user with this additional feature: Slightly Curved Former with Independent/Displaced thumb.
Ask a Question
K Number
K071465Device Name
BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENT
Manufacturer
MOLNLYCKE HEALTHCARE, US LLC
Date Cleared
2007-09-11
(105 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
MOLNLYCKE HEALTHCARE, US LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Biogel Orthopedic Surgeon's Glove is a disposable device made of natural rubber latex that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.
Device Description
The Biogel Orthodepic Surgical Glove is a sterile powder free, polymer coated latex surgical glove. The glove contains 50 micrograms or less of total water extractable protein per gram.
Ask a Question
K Number
K071700Device Name
BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENT
Manufacturer
MOLNLYCKE HEALTHCARE, US LLC
Date Cleared
2007-09-11
(82 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
MOLNLYCKE HEALTHCARE, US LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Biogel® Sensor™ Surgeon's Glove is a sterile disposable device made of natural rubber latex that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.
Device Description
The Biogel® Sensor™ Surgeon's Glove is a sterile powder free, polymer coated latex surgical glove. The glove contains 50 micrograms or less of total water extractable protein per gram.
Ask a Question
Page 1 of 1