N95 respirators are intended for use in a health care setting. Specifically, single-use, disposable respiratory protective devices used and worn by health care personnel during procedures to protect both the patient and health care personnel from the transfer of microorganisms, body fluids, and particulate material. These surgical N95 respirators are class II devices regulated by the FDA, under 21 CFR 878.4040, and CDC NIOSH under 42 CFR Part 84.
N95s respirators regulated under product code MSH are class II medical devices exempt from 510(k) premarket notification, unless:
The respirator is intended to prevent specific diseases or infections, or
The respirator is labelled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or
The respirator contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms).
Specifications - KN95 Mask
Testing and Approval - Evaluated, tested, and approved by NIOSH as per the requirements in 42 CFR Part 84.
Intended Use and Purpose - Reduces wearer’s exposure to particles including small particle aerosols and large droplets (only non-oil aerosols).
Face Seal - Tight-fitting
Fit Testing Requirement - Yes
User Seal Check Requirement Yes. Required each time the respirator is donned (put on)
Filtration - Filters out at least 95% of airborne particles including large and small particles
Leakage - When properly fitted and donned, minimal leakage occurs around edges of the respirator when user inhales
Use Limitations - Ideally should be discarded after each patient encounter and after aerosol generating procedures. It should also be discarded when it becomes damaged or deformed; no longer forms an effective seal to the face; becomes wet or visibly dirty; breathing becomes difficult; or if it becomes contaminated with blood, respiratory or nasal secretions, or other bodily fluids from patients
Once the order is confirmed, it will take 2 - 3 working days for deliveries within Colombo and 5 - 7 working days for deliveries outside Colombo The following standard delivery charges are applicable for products below 1 kg:
Colombo 1-15 - Rs 200
Colombo Suburbs - Rs 250
Outstation - Rs 350
Orders which are over 1kg will be charged at a flat rate of Rs.50/- per kg on top of the standard rates stipulated above. Orders which are above 5kg in weight and large in size will be charged a flat rate of Rs.250/- on top of the standard delivery rates as stipulated above.
Orders are processed and delivered Monday-Friday (excluding public holidays)
IMPORTANT NOTE FOR ALL PRE-ORDER PRODUCTS
Orders shipped from overseas can take between 30 days – 60 days to receive. Your money back guarantee applies and you will receive a full refund should you not receive your product during this time.
Cash-on-delivery options will not be available for any PRE-ORDER products and we may cancel the order if there is no payment made.