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510(k) Data Aggregation
K Number
K193573Device Name
Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro
Manufacturer
Molnlycke Health Care US LLC.
Date Cleared
2020-04-10
(109 days)
Product Code
KGO, LZC
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
Molnlycke Health Care US LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Skinsense polyisoprene underglove is a disposable device made of polyisoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The Biogel PI Micro Surgical Glove is a disposable device made of polyisoprene material that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
A powder-free sterile surgeon's glove is a disposable device made of polyisoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
A powder-free, sterile, surgeon's glove is a disposable device made of non-latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Device Description
The Biogel® surgical gloves that are the subject of this submission are sterile, single-use, powder-free gloves that are constructed of either synthetic polyisoprene or synthetic polychloroprene.
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