(141 days)
Nasal Ease Allergy Blocker is intended to treat hay fever and allergy sufferers by promoting alleviation of mild allergic symptoms (i.e. mild nasal irritation including itchy, runny, or congested nasal passages) triggered by the inhalation of various airborne allergens including indoor and outdoor environmental pollens, house dust, animal hairs and dust mites.
Application of Nasal Ease produces a mucous-like gel barrier that evenly coats the nasal membranes and acts to block inhaled allergens within the nasal cavity.
Nasal Ease Allergy Blocker is composed of 100% pharmaceutical grade Hydroxypropyl Methylcellulose (HPMC) which has been formulated into a micronized powder of fine particles of inert cellulose. Nasal Ease is administered by insufflation into the nose using a proprietary spray bottle which enables the powder to be applied evenly as a fine mist to the inside of the nasal cavity.
When Nasal Ease powder comes into contact with the moist surface of the nasal mucosa, it almost immediately forms a colorless, mucus-like fine gel which coats the inside of the nasal cavity. The inert gel acts as a mechanical barrier ~ making it more difficult for inhaled allergens to come into contact with the nasal interior, and thus reducing the intensity of allergic rhinitis symptoms.
One bottle squeeze releases around 3.2mg of powder. The maximum usual dose is around 3 puffs/day into each nostril, giving a total of 19mg/day.
The cellulose gel is considered inert and does not penetrate the dermal layer of the skin. On average, protection lasts for 4-6 hours before the gel has to be re-applied. Nasal Ease is intended for topical use and provided non-sterile.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Particle Size Distribution | 99.4% of particles in the 5-500 micron (um) diameter range. Mean particle size of 118 um. No particles |
§ 880.5045 Medical recirculating air cleaner.
(a)
Identification. A medical recirculating air cleaner is a device used to remove particles from the air for medical purposes. The device may function by electrostatic precipitation or filtration.(b)
Classification. Class II (performance standards).