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510(k) Data Aggregation
K Number
K190782Device Name
FlexGard Cut-Resistant Glove Liners
Manufacturer
Date Cleared
2019-06-27
(92 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
LDI Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The FlexGard® Cut-Resistant Glove Liners are single use glove liners intended to help with protection against cuts when used with an inner and outer surgical glove. The glove liner must be worn between two surgical gloves.
Device Description
The FlexGard Cut Resistant Glove Liners provide an optional method of providing cut resistance to surgical gloves. The FlexGard Cut Resistant Glove Liners are applied between layers of surgical gloves. The FlexGard Cut Resistant Glove Liners are placed over a surgical glove and subsequently covered by a surgical glove.
The FlexGard Cut Resistant Glove Liners are ambidextrous, there is no left or right handed Glove Liner variations.
The FlexGard Cut Resistant Glove Liners are provided to the user terminally sterilized by a validated ethylene oxide process. The FlexGard Cut Resistant Glove Liners are labeled for single use.
The FlexGard Cut Resistant Glove Liners provide protection against cuts and slashes. The FlexGard Cut Resistant Glove Liners are not puncture resistant or cut proof.
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