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510(k) Data Aggregation
K Number
K101163Device Name
BIOGEL ORTHOPRO INDICATOR UNDERGLOVE
Manufacturer
Date Cleared
2010-11-23
(211 days)
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
MOLNLYCKE HEALTH CARE USA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Biogel® OrthoPro® Indicator® Underglove 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® Indicator® Underglove is manufactured of natural rubber latex. The Biogel® OrthoPro® Indicator® Underglove 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.
The glove former design used in the manufacture of this glove allows the Biogel® OrthoPro® Indicator Underglove to provide the user with these additional features:
- . Slightly Curved Former with Independent/Displaced thumb
- Improved Fit, Feel and Comfort (compared to the current Biogel" Orthopaedic Surgical Glove)
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