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510(k) Data Aggregation
K Number
K052387Device Name
ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX
Manufacturer
ARTHREX, INC.
Date Cleared
2005-11-29
(90 days)
Product Code
LZB
Regulation Number
880.6250Why did this record match?
Product Code :
LZB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Arthrex Fingershield finger guards are intended to be used over surgical gloves for the protection of wearer while tensioning suture or tying knots with suture products.
Device Description
The Arthrex Fingershield Finger Guards are woven polyester with a marker thread of radio opaque Micropake®. These are offered in a one size fits all cylinder shape. They are offered sterile.
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K Number
K992539Device Name
PERCUGUARD
Manufacturer
DIGIT-PRO
Date Cleared
2000-02-18
(203 days)
Product Code
LZB
Regulation Number
880.6250Why did this record match?
Product Code :
LZB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of PERCUGUARD ™ is to prevent accidental needle stick and/or sharps injuries to healthcare workers on the fingers and thumbs exposed lo injuries.
It is a protective finger guard accessory to the examination glove. It is used on the finger and/or the thumb of the non-dominant hand usually used to retract, stabilize. or isolate in preparation for an injection procedure. Il may be inverted and used to prevent accidental needle sticks while suluring. It can be used on the dominant hand (device inverted) when isolating, retracting, stabilizing, or palpating tissue where sharp bone or wires are present in order to protect the palm side of the fingers or thumbs
Device Description
Not Found
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K Number
K980827Device Name
LATEX FINGER COT, POWDER-FREE, WITH PROTEIN LABELING
Manufacturer
TUCKER & ASSOCIATES
Date Cleared
1998-05-04
(62 days)
Product Code
LZB
Regulation Number
880.6250Why did this record match?
Product Code :
LZB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A finger cot is a disposable device intended for medical purposes that is worn on the examiner's finger to prevent contamination between patient and examiner.
Device Description
Latex Finger Cot, Powder-Free, with Protein Labeling
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