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510(k) Data Aggregation
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?
Applicant Name (Manufacturer) :
DIGIT-PRO
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
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