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510(k) Data Aggregation
K Number
K143177Device Name
KleenGel Dispenser
Manufacturer
KleenGel, LLC
Date Cleared
2015-09-14
(314 days)
Product Code
KYX, KMJ
Regulation Number
880.6430Why did this record match?
Applicant Name (Manufacturer) :
KleenGel, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KleenGel hands-free dispenser is used to dispense lubricating gel for use by healthcare providers when performing pelvic and rectal exams and other procedures requiring lubricating gel.
Device Description
The KleenGel Dispenser is a patented automatic dispenser designed to efficiently and hygienically dispense lubricating gel for use by health care providers when performing pelvic and rectal exams or other procedures requiring the use of lubricating gel. The KleenGel Dispenser has an Infrared Sensor for automatic dispensing of lubricating gel onto the providers fingers or on a medical instrument. The unit is designed to be placed on a counter top so it's easily accessible to healthcare providers in exam rooms. The device is battery operated, using four (4) AA (1.5V) batteries. Device also has an optional AC adapter. Sterile Lubricating Gel, (sold separately) is packaged in a 14 oz pre-filled disposable cartridge. Gel is dispensed in 3 volume selections, 1ml, 2ml or 3ml.
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