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510(k) Data Aggregation
K Number
K042250Device Name
SENSATOUCH
Manufacturer
Date Cleared
2004-11-12
(84 days)
Product Code
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
ALUNA MANAGEMENT CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
SensaTouch™ is indicated as an aid for performing breast self-examinations.
Device Description
The SensaTouch™ - Breast Self-Exam Glove is a very thin double wall polyurethane glove, 8 inches in diameter containing a small quantity of colored lubricating fluid. The very thin nature of the polyester polyurethane allows the glove to conform to the shape of the tissues underlying it. The very low coefficient of friction property of the silicone fluid in combination with the very thin and flexible glove, provides easy sliding between the upper and lower surfaces of the glove. Therefore, when properly used between the fingers and the soft breast tissues of the patient, a reduction of friction is observed.
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