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510(k) Data Aggregation
K Number
K992702Device Name
EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM
Manufacturer
ALLERGY DIRECT
Date Cleared
1999-11-08
(88 days)
Product Code
FMW
Regulation Number
880.6190Why did this record match?
Applicant Name (Manufacturer) :
ALLERGY DIRECT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
eVENT™ Allergen Barriers have been designed exclusively for allergy sufferers wishing to reduce their exposure to house dust mite allergens in mattresses, pillows and duvel/comforters.
Device Description
eVENT™ Allergen Barriers consist of mattress, pillow and duvet/comforter encasings. The products consist of an expanded PTFE membrane laminated to a synthetic or synthetic/natural combination fabric. The expanded PTFE membrane provides a moisture-vapor & air permeable ("breathable") barrier with pores too small to allow passage to either house dust mites or their allergen containing fecal droppings. The fabric component provides a strong, easily maintained support for the ePTFE membrane. EVENT™ Allergen Barrlers are soft, comfortable and easy to clean; They are simply damp-dusted when the bed sheets are changed. Allergydirect.com's membrane manufacturing process is sufficiently controlled to ensure uniform nominal pore sizes too small to permit the Allergen Barners provide high levels of protection from house dust mite allergens. The membrane's vapor permeable characteristics help promote sleeping comfort. Thus, eVENT™ Allergen Barriers serve as an effective barrier between a patient and a cause of their allergies; this results in a healthier, more comfortable sleeping environment.
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