FITTING TIP: When your Vogmask arrives, the ear loops are measured within variance according to Quality Plan. If the ear loops are too short, gently stretch the loops until you hear indication of loosening of spandex, then try the mask on for more comfortable adjusted length ear loop.
What is the classification and intended use for Vogmask?
Vogmask is designed as Filtering half masks to protect against particles.
Our product is Korean Ministry of Food and Drug Safety Certified KF-94, GB2626-2006 Personal Protective Equipment Certified KN95, and Certified for CE Mark Personal Protective Equipment - filtering half masks for particles, against EN 149:2001 + A1:2009 . Vogmask conforms to NIOSH N99 filter efficiency as stated in 42 CFR Part 84.181.
Vogmask is NOT classified as Masks to prevent disease – Regulated under CDRH/FDA as Class II medical devices subject to premarket notification 510(k), classified as surgical mask 21 CFR 878.4040. Surgical masks are not PPE, they protect the patient and the surgical area from contamination. Surgical masks prevent droplets being expelled into the environment by the wearer and protect patients in surgery from these being transferred to the operative site.
Respirators are PPE and are designed and used to reduce the potential exposure of the wearer to airborne hazardous contaminants.
The following is a functional description of the Vogmask and its intended use:
Certain limitations apply to the use of the Vogmask product: